Serum creatinine ? 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ? 60 mL/minute Serum creatinine < 2.0 mg/dL or creatinine clearance >= 50 mL/minute Creatinine clearance greater than or equal to (>=) 30 milliliters per minute (mL/min) Within 14 days of the first dose of study drug: Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance > 40 mL/minute (using Cockcroft/Gault formula) A pretreatment measured creatinine clearance (absolute value) of >= 60 ml/minute Serum creatinine of =< 1.5 X ULN or creatinine clearance > 40 mL/minute (using Cockcroft/Gault formula) Serum creatinine clearance or radioisotope GFR ?50 milliliters/minute/1.73 m^2, based on a 12 or 24 hours (h) urine creatinine collection. Creatinine within institutional normal limits or, clearance > 60 mL/ minute if serum creatinine is elevated above institution upper limit (UL) Adequate renal function defined as serum creatinine <1.5 × upper limit of normal (ULN) (or use System of Units [SI] units or calculated creatinine clearance ?50 milliliter per minute [mL/min] per the Cockcroft and Gault formula) Patients must have adequate organ and bone marrow function within 14 days prior to registration, as defined by: serum creatinine of =< 3.0 X ULN (upper limit of normal) or creatinine clearance >= 30 mL/minute (using Cockcroft/Gault formula) Pretreatment calculated or measured creatinine clearance (absolute value) of >= 60 mL/minute. Obtained within 14 days of randomization: Creatinine serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance > 40 mL/minute (using Cockcroft/Gault formula) Calculated creatinine clearance must be >= 30 mL/minute Serum creatinine =< 1.5 times the ULN, or calculated creatinine clearance >= 50 mL/minute (per the Cockcroft-Gault formula) Creatinine ? 1.5 x the upper limit of normal (ULN), or calculated creatinine clearance ? 60 mL/minute x 1.73 m2 per the Cockcroft-Gault formula Estimated creatinine clearance less than 50 ml/minute Creatinine clearance >= 30 ml/minute Creatinine ? 1.5x the upper limit of normal (ULN), or calculated creatinine clearance ? 60 mL/minute x 1.73 m^2 per the Cockcroft-Gault formula Creatinine =< 2.0 x ULN (for patients with > 1.5 x ULN, calculated or measured creatinine clearance must be = 40 mL/minute [Cockcroft-Gault]). A pretreatment measured creatinine clearance (absolute value) of >= 50 ml/minute Adequate renal function as defined by: calculated creatinine clearance must be >= 40 mL/minute (Cockcroft-Gault) Calculated creatinine clearance (absolute value) of >= 50 mL/minute or creatinine < 2.0 mg/dl or < 2 times upper limit of normal for the research participant's age group If the research participant is to undergo leukapheresis, he/she must have a pretreatment calculated creatinine clearance of >= 50 mL/minute Estimated or measured creatinine clearance >= 45 mL/minute Creatinine ? 1.5 x the upper limit of normal (ULN), or calculated creatinine clearance ? 50 mL/minute x 1.73 m2 per the Cockcroft-Gault formula Serum creatinine < 1.5 mg/dl or creatinine clearance greater than 60/ ml per minute by the following formula (all tests must be performed within 28 days prior to registration) Creatinine clearance >= 40 mL/minute (measured or calculated/estimated) A pretreatment measured creatinine clearance (absolute value) of >= 60 mL/minute Serum creatinine =< 1.5 × ULN, OR calculated creatinine clearance >= 30 mL/minute (modified Cockcroft and Gault formula) Serum creatinine ?1.5 × ULN or calculated creatinine clearance ?50 milliliters/minute. Serum creatinine < 1.5 times the ULN, or creatinine clearance > 60 mL/minute as calculated by the standard Cockcroft-Gault formula Have adequate renal function as defined by creatinine clearance >30 milliliters/minute. serum creatinine clearance ?60 mL/minute Calculated creatinine clearance > 50 mL/minute (Appendix 4) Creatinine clearance >= 60 ml/minute Calculated creatinine clearance must be >= 30 mL/minute Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance > 40 mL/minute (using Cockcroft/Gault formula) Participant has serum creatinine ? 1.5 x ULN. If serum creatinine > 1.5 x ULN the calculated creatinine clearance should be > 40 milliliters/minute (mL/min) Have calculated creatinine clearance (CrCL) ?30 mL/minute or serum creatinine ?1.5 times below the upper limit of normal. Serum creatinine ? 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ? 60 mL/minute Severe chronic renal disease (serum creatinine > 2.0 mg/dl and confirmed by creatinine clearance < 40 mL/minute) Creatinine clearance (CrCl) >= 15 mL/minute, either measured or calculated Serum creatinine of =< 1.5 X upper limit of normal (ULN) or creatinine clearance > 40 mL/minute (using Cockcroft/Gault formula) Calculate creatinine clearance >=40 millilitre/ minute (mL/min) (With the exception of those subjects who have Gilbert's syndrome; the bilirubin in these subjects should be at their baseline) Calculated creatinine clearance ? 30 milliliter per minute (mL/min). Creatinine clearance > 50 mL/minute within 30 days prior to cycle 1 day 1, either measured or calculated using a standard formula Patient has a calculated or measured creatinine clearance of < 30 mL/minute Estimated creatinine clearance (Clcr) >= 30 mL/minute Adequate renal function as defined by: calculated creatinine clearance must be at least 40 mL/minute (Cockcroft-Gault) Patients must have an estimated creatinine clearance greater than 50/ml per minute (serum creatinine value must be within 28 days prior to registration) Patient has a calculated or measured creatinine clearance of < 20 ml/minute within 14 days before enrollment Serum creatinine ?1.5 x ULN or calculated 24-hour creatinine clearance ?60 mL/minute Patients must have a creatinine clearance greater than 50/ml per minute by the following formula (test must be performed within 28 days prior to registration):\r\n* Creatinine clearance (CrCl) = (140-age) (Wt in Kg) x 0.85 (female) OR 1.0 (male)/72 x serum Cr Baseline serum-creatinine > 2.0 mg/dl and a calculated or measured creatinine clearance of < 50 ml/minute Patients must have adequate renal function defined as creatinine clearance of >= 30 ml/minute (Cockcroft-Gault) Adequate renal function (creatinine clearance greater than equal to (?) 45 milliliters per minute [mL/min]) Creatinine clearance >= 30 mL/minute Creatinine =< 1.5x institutional upper limit of normal (IULN), and/or an adequate renal function as defined by: calculated creatinine clearance must be >= 40 mL/minute (Cockcroft-Gault) Has adequate organ function: AST and ALT < 3X the ULN, serum bilirubin < 2X the ULN, serum creatinine of < 2 mg/dL, or a calculated creatinine clearance of > 50 mL/minute Serum creatinine ? 1.5 × upper limit of normal (ULN) or creatinine clearance > 40 mL/minute (using Cockcroft/Gault formula) Measured creatinine clearance or calculated creatinine clearance > 30 mL/minute. Note: If a calculated creatinine clearance is used, it should be calculated according to the Cockcroft-Gault formula. Serum creatinine <=1.2 mg/dL or calculated/measured creatinine clearance >=50 mL/minute Has adequate renal function, defined as: Creatinine clearance >= 60 mL/minute, as calculated using the modified Cockroft Gault equation, ([{140 - age in year Serum creatinine =< 1.5 x ULN; estimated creatinine clearance using the Cockcroft-Gault formula must be > 50 mL/minute OR a measured 24-hour creatinine clearance must exceed > 50 mL/minute Adequate renal function as defined by serum creatinine ? 1.5 x ULN. If creatinine >1.5 x ULN, calculated or measured creatinine clearance must be ? 40 mL/minute (Cockcroft-Gault). Serum creatinine ?2 mg/dL or creatinine clearance > 60 mL/minute; Patient has a calculated or measured creatinine clearance of < 20 mL/minute within 14 days prior to treatment initiation Serum creatinine =< ULRR or creatinine clearance >= 50 mL/minute (calculated by Cockcroft-Gault formula or measured in a timed urine collection) Creatinine clearance (CrCl) ? 50 mL/minute within 21 days prior to randomization The participant has adequate renal function as defined by serum creatinine ? 1.5 x the institutional ULN or creatinine clearance ? 60 milliliter/minute (mL/min) for participants with creatinine levels above the ULN Serum creatinine > 1.5 x upper limit of normal (ULN) or creatinine clearance < 60 mL/minute Have adequate renal function defined as a creatinine clearance ?50 mL/minute (calculated according to the formula of Cockcroft and Gault 1976) or serum creatinine <1.5 mg/dL. Renal: creatinine clearance >=60 milliliter per minute (mL/min). Adequate renal function as evidenced by calculated creatinine clearance ?30 milliliters (mL)/minute according to the Cockcroft and Gault formula Creatinine clearance (calculated or measured) of < 50 cc/minute Creatinine clearance ?60 milliliters/minute. Serum creatinine > 1.5 x ULRR or creatinine clearance < 30 mL/minute (calculated by Cockcroft-Gault formula) Subjects with renal insufficiency (estimated creatinine clearance less than 20 mL/minute at baseline or likely to require dialysis during the study) Creatinine =< 1.5 x upper normal institutional limits (UNL) OR creatinine clearance >= 40 mL/min based either on Cockcroft-Gault estimate or based on urine collection (12 or 24 hour) Calculated (Calc.) creatinine clearance >= 30 mL/min; calculated utilizing the Cockcroft-Gault formula or 24-hour urine collection RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Calc. creatinine clearance >= 30 mL/min\r\n* Calculated utilizing the Cockcroft-Gault formula or 24-hour urine collection Serum creatinine =< 1.5 mg/dl or calculated creatinine clearance (CC) >= 50 ml/min determined by 24-hour urine collection or estimated by Cockcroft-Gault formula, within 21 days prior to registration Estimated creatinine clearance >= 30 mL/min according to the Cockcroft-Gault formula or by 24-hour urine collection for creatinine clearance or according to local institutional standard Creatinine clearance >= 40 mL/min per 24 hour urine collection or the Cockcroft-Gault formula Creatinine clearance >= 50 mL/min based either on Cockcroft-Gault estimate or based on urine collection (12 or 24 hour) Serum creatinine =< 1.5 x institutional upper limit of normal or creatinine clearance > 60 mL/min/1.73 m^2 (per 24 hour urine collection or calculated according to the Cockcroft-Gault formula) for subjects with creatinine levels above the institutional normal Creatinine clearance of ? 60 mL/min as estimated by the Cockcroft-Gault equation or by 24 hour urine collection. Serum creatinine clearance > 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance Renal status: Creatinine clearance ?50 mL/min based on Cockcroft-Gault estimate or based on urine collection (12 or 24 hour); Glomerular filtration rate > 40ml/min/1.73m^2 as estimated by the Cockcroft-Gault formula or creatinine clearance > 50ml/min as determined by 24-hour urine collection Creatinine clearance >= 45 ml/min determined by 24-hour collection or estimated by the Cockroft-Gault formula Creatinine clearance >= 45 mL/min calculated by Cockcroft-Gault or 24 hour collection Estimated creatinine clearance greater than 60 mL/min determined by 24-hour urine sampling or by the Cockcroft- Gault formula Adequate renal function defined by an estimated creatinine clearance > 30 mL/min according to the Cockcroft-Gault formula or be measure for creatinine clearance from 24 hour urine collection. Should be performed within 10 days of treatment initiation: serum creatinine clearance (CL) > 60 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance Subject must have adequate renal function as demonstrated by a calculated creatinine clearance ? 30 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula An estimated creatinine clearance > 30 mL/min according to the Cockcroft-Gault formula or be measure for creatinine clearance from 24-hour urine collection. Creatinine clearance >=50 mL/min based either on Cockcroft-Gault estimate or based on urine collection (12 or 24 hour). Creatinine within normal institutional limits OR, creatinine clearance > 40 mL/min by Cockcroft-Gault or 24h urine collection. Creatinine clearance >= 40 ml/min as determined by 24-hour collection or estimated by the Cockcroft-Gault formula (measured within 28 days of registration) Creatinine outside normal limits OR, if creatinine outside normal limits, a creatinine clearance <60 mL/min (measured by 24-hour urine collection or calculated by Cockcroft and Gault equation (Cockcroft and Gault 1976). Renal function, as follows: Dose Escalation, NSCLC, Ovarian, and CPI Treated Expansion Cohorts: creatinine clearance of ? 30 mL/min by the Cockcroft-Gault equation or as measured by 24 hour urine collection. For the Renal Insufficiency Expansion Cohort: creatinine clearance estimate ?15 ml/min and <30 ml/min by Cockcroft-Gault equation or as measured by 24 hour urine collection. Obtained within 28 days prior to registration: serum creatinine < 1.5 mg/dl or creatinine clearance (CC) >= 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula Serum creatinine clearance (CL) =< 1.5 x ULN or creatinine clearance > 45 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance Adequate renal function defined by an estimated creatinine clearance > 50 mL/min according to the Cockcroft-Gault formula or by measure of creatinine clearance from 24 hour urine collection Creatinine =< 1.5 x ULN and requires creatinine clearance (CrCl) >= 60ml/min (per 24-hour urine collection or calculated according to the Cockcroft-Gault formula) Creatinine clearance >= 50 ml/min by Cockcroft-Gault formula or 24 hour urinary clearance Serum creatinine clearance (CL) > 50 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance Creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance Patients must be considered ineligible for cisplatin\r\n* Cisplatin ineligibility is defined as meeting at least one of the following criteria\r\n** Creatinine clearance (calculated or measured) < 60 mL/min (but >= 30 mL/min) calculated by Cockcroft-Gault equation (using actual body weight) or by measured 24-hour urine collection of creatinine for determination\r\n** Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2 audiometric hearing loss\r\n** New York Heart Association class III/IV heart failure\r\n** Eastern Cooperative Oncology Group (ECOG) performance status of 2 as determined by treating investigator Calculated or measured creatinine clearance < 60 mL/min (but >= 30 mL/min) calculated by Cockcroft-Gault equation (using actual body weight) or by measured 24-hour urine collection of creatinine for determination Serum creatinine =< mg/dl or creatinine clearance (CC) >= 50 ml/min determined by 24 hour collection or estimated by Cockcroft-Gault formula Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance. Creatinine clearance (CrCl) >= 30 mL/min., as measured by a 24-hour urine collection, or estimated by the Cockcroft and Gault formula No more than 14 days prior to registration: Serum creatinine clearance > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance Serum creatinine clearance (CL) > 50 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance Creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance. Serum creatinine ?1.5 x ULN or creatinine clearance ?50 mL/min based on either urine collection or Cockcroft Gault estimation. Creatinine clearance >= 50 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) based either on Cockcroft-Gault estimate or based on a 12- or 24-hour urine collection. Serum creatinine level =< 1.5 x ULN and clearance (CL) > 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance within 28 days prior to study registration Creatinine clearance >= 50 mL/min based either on Cockroft-Gault estimate or based on urine collection (12 or 24 hour) To be performed within 10 business days prior to day 1: Creatinine clearance of >= 50 mL/min per the Cockcroft-Gault formula and/or 24 hour (hr) urine analysis as needed Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance Creatinine clearance >= 50 mL/min based either on Cockcroft-Gault estimate or based on urine collection (12 or 24 hour) Creatinine within normal limits OR, for patients with levels above institutional normal: creatinine clearance measured by 24-hour urine collection >= 60 mL/min, OR calculated corrected creatinine clearance >= 60 mL/min/1.73 m^2 using the Cockcroft-Gault formula (Cockcroft and Gault 1976) corrected for the body surface area Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance Creatinine > 1.5 x ULN, or a creatinine clearance of < 60 ml/min as calculated by Cockcroft-Gault or by 24-hour urine collection Within 14 days prior to registration: Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance Creatinine clearance >= 50 mL/min based either on Cockroft-Gault estimate or based on urine collection (12 or 24 hour) Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine Renal: creatinine < 1.5 X ULN or creatinine clearance >= 50 mL/min based either on Cockcroft-Gault estimate or based on urine collection (12 or 24 hour) Creatinine clearance >= 50 mL/min (calculated using the Cockroft-Gault formula or measured with 24 hour urine collection) Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance Creatinine clearance >= 50 mL/min based either on Cockcroft-Gault estimate from serum creatinine or based on urine collection (12 or 24 hour) Serum creatinine clearance (CL) > 50 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance Serum creatinine within the institutional normal limits, OR if the creatinine is elevated: creatinine clearance (CrCl) >= 30 mL/min., as measured by a 24-hour urine collection, or estimated by the Cockcroft and Gault formula Serum creatinine clearance < 60 ml/min on the basis of either 24-hour urine collection or the glomerate filtration rate estimated by Cockraft-Gault equation Within 14 days of first dose of study drug administration: Serum creatinine: creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance Calculated creatinine clearance (CrCl) >= 50 mL/min per 24 hour urine collection or the Cockcroft-Gault formula Calculated creatinine clearance (CrCl) >= 30 mL/min per 24-hour urine collection or the Cockcroft-Gault formula Either an estimated creatinine clearance value of >= 50 mL/min as determined by the Cockcroft-Gault formula or a creatinine clearance value of >= 50 mL/min based on a 24 hour urine collection Calculated creatinine clearance of < 30 mL/min using Cockcroft Gault or measured by 24 hour urine Adequate renal function, as defined by creatinine clearance of ? 50 ml/min (as estimated by the Cockcroft-Gault equation or as measured by nuclear medicine scan or 24 hour urine collection). Creatinine clearance (CC) >= 50 ml/min within 4 weeks prior to registration determined by 24-hour collection or estimated by Cockcroft-Gault formula Obtained =< 28 days prior to randomization:\r\nCreatinine =< 1.5 mg/dL OR calculated creatinine clearance of >= 50 ml/min by either the Cockcroft-Gault formula or 24-hours urine collection analysis Creatinine within normal institutional limits OR creatinine clearance > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance Adequate renal function within 4 weeks of study entry, defined as serum creatinine less than or equal to 1.5 x ULN for the lab. (If creatinine is 1.0-1.5 x ULN, the creatinine clearance should be greater than 40 mL/min per Cockcroft-Gault formula (Cockcroft-Gault 1976), or by 24-hour urine collection for determination of creatinine clearance.) Creatinine clearance ? 30 mL/min/1.73 m^2 by Cockcroft-Gault\r\n* At the discretion of the treating physician, a 24-hour urine creatinine clearance could be obtained and utilized as the gold standard if creatinine clearance by Cockcroft-Gault is < 30, and prevents patient enrollment on the trial To be performed within 14 days prior to day 1 of protocol therapy: creatinine clearance of >= 50 mL/min per 24 hour urine or the Cockcroft-Gault formula Creatinine clearance >60 mL/min (calculated using the Cockcroft-Gault formula) or by 24-hours urine collection Measured creatinine clearance (CL) >= 50 mL/min or calculated creatinine CL ? 50 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance within 3 weeks prior to initial treatment Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Creatinine clearance of >= 60 mL/min per 24 hour urine test or the Cockcroft-Gault formula Serum creatinine clearance (CL) >40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance. Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance Creatinine clearance >= 50 mL/min (calculated by the Cockcroft-Gault or via 24-hour urine collection) Within 14 days prior to step 1 registration: Measured creatinine clearance (CL) > 30 mL/min or calculated creatinine CL > 30 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance Creatinine within normal institutional limits OR creatinine clearance >= 30 Ml/min (Cockcroft-Gault formula or measured with 24 hour [h] urine) Creatinine clearance (CrCl) >= 50 ml/min within 14 days prior to registration as determined by 24-hour collection or estimated by Cockcroft-Gault formula Serum creatinine institutional ULN within 14 days prior to registration or; creatinine clearance (CC) >= 50 ml/min within 14 days prior to registration determined by 24-hour collection or estimated by Cockcroft-Gault formula Obtained within 14 days (or as stipulated) prior to study drug (treatment) administration: creatinine clearance ? 30 ml/min (calculated by the Cockcroft-Gault Equation or per 24-hour urine collection) Creatinine clearance > 60 mL/min/1.73 m^2 by either Cockcroft-Gault formula or 24-hour urine collection analysis Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance Serum creatinine < 2 x institutional ULN or creatinine clearance > 50 ml/min as determined by 24 hour collection or estimated by Cockcroft-Gault formula Creatinine clearance of >= 45 mL/min per 24 hour urine collection or the Cockcroft-Gault formula Creatinine clearance >= 45 ml/min determined by 24-hour collection or estimated by the Cockroft-Gault formula Serum creatinine =< 1.5 mg/dl or creatinine clearance (CC) >= 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula, within 14 days prior to registration Creatinine clearance >= 50 mL/min by either Cockcroft-Gault formulate or 24 hour (hr) urine collection analysis Creatinine clearance >= 50 ml/min within 2 weeks prior to registration as determined by 24-hour collection or estimated by Cockcroft-Gault formula Creatinine < 1.5 mg/dL or within normal institutional limits within 10 days prior to registration; Note: if neither criteria is met, the creatinine clearance must be > 50 mL/min/1.73 m^2 per either the Cockcroft-Gault equation, Jeliffe method, or 12- or 24-hour urine collection Serum creatinine < 2 x institutional ULN or; creatinine clearance (CC) >= 50 mL/min determined by 24-hour collection or estimated by Cockcroft-Gault formula Creatinine clearance (CrCL) >= 30 mL/min, measured by a 24-hour urine collection or estimated by the Cockcroft and Gault formula within 14 days prior to registration Creatinine clearance >= 40 mL/min/1.73 m^2 by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance Patients must have a calculated serum creatinine clearance > 50 mL/min using Cockcroft-Gault calculation or based on 24-hour urine collection performed within 7 days prior to treatment Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance, obtained within 14 days prior to first treatment Serum creatinine 1.5 × ULN or calculated creatinine clearance (per the Cockcroft-Gault formula or equivalent and/or 24-hour urine collection) 60 milliliters/minute (mL/min). Creatinine clearance >= 40 ml/min as determined by 24-hour collection or estimated by the Cockcroft-Gault formula Serum creatinine =< 1.5 mg/dl or creatinine clearance (CC) >= 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula within 30 days prior to registration Creatinine =< 2.0 mg/dL OR creatinine clearance >= 50 mL/min as determined by the Cockcroft-Gault equation or a 24 hour urine collection Creatinine within normal institutional limits OR creatinine clearance > 40 mL/min per 24 hour (h) urine collection or calculated according to the Cockcroft-Gault formula Calculated creatinine clearance > 30 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance Serum creatinine clearance > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance Serum creatinine clearance (CL) >= 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance Calculated by Cockcroft-Gault or measured by 24 hour urine creatinine clearance >= 50 mL/minn Calculated (method of Cockcroft-Gault) creatinine clearance (CrCl) >= 60 mL/min (creatinine clearance may also be obtained by the 24-hour collection method at the investigator’s discretion) Renal function: A calculated creatinine clearance value of ? 50 mL/min as determined by the Cockcroft Gault formula or a creatinine clearance value of ? 50 mL/min based on a 24-hour urine collection; Serum creatinine =< 2.0 x upper limit of normal OR calculated creatinine clearance >= 30 ml/min/1.73 M^2 by the modified Cockcroft and Gault formula OR creatinine clearance >= 30 mL/min obtained from a 24-hour urine collection Cr Cl ? 50 mL/min (as determined by the Cockcroft-Gault equation or by 24-hour urine collection) Creatinine =< 1.5 x institutional upper limits of normal or creatinine clearance of > 40 mL/min per 24 hour (h) urine collection or calculated according to the Cockcroft-Gault formula Creatinine clearance of > 50 mL/min per 24 hour urine collection of the Cockcroft-Gault formula Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance Creatinine clearance =< 50 mL/min based either on Cockroft-Gault estimate or based on urine collection (12 or 24 hour) Calculated creatinine clearance > 30 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance Creatinine clearance ?40 mL/min based on Cockcroft-Gault estimate or based on a 12- or 24-hour urine collection. Serum creatinine =< 1.5 X upper limit of normal (ULN) OR calculated creatinine clearance >= 30 mL/min as calculated by Cockcroft-Gault formula or by 24 hour urine collection, performed within 10 days of protocol enrollment Must have creatinine ? 1.5 × institutional ULN or Creatinine Clearance > 50 ml/min (as calculated by the Cockcroft-Gault equation) within 14 days prior to randomization. Serum creatinine =< 1.5 X institutional ULN and creatinine clearance >= 60 ml/min\r\n* NOTE: creatinine clearance must be calculated using the Cockcroft-Gault equation Calculated creatinine clearance >= 45 mL/min by Cockcroft-Gault equation Within less than or equal to 14 days prior to registration: Serum creatinine =< 1.5 X institutional ULN and creatinine clearance >= 60 ml/min\r\n* NOTE: Creatinine clearance must be calculated using the Cockcroft-Gault equation Creatinine clearance >= 25 ml/min (using the Cockcroft-Gault equation), documented within 14 days of registration Estimated creatinine clearance of > 50 ml/min (0.84 mL/s) by the Cockcroft-Gault equation Subject has adequate renal function with an estimated creatinine clearance of ? 30 mL/min by the Cockcroft-Gault equation adjusted for body weight Calculated creatinine clearance (CrCl) >= 50 mL/min (based upon the Cockcroft-Gault equation) Calculated creatinine clearance >= 30 mL/min as determined by the Cockcroft-Gault equation Creatinine clearance >= 30 mL/min (Cockcroft-Gault equation) Serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 50 mL/min; for creatinine clearance estimation, the Cockcroft and Gault equation should be used, within 14 days before the first dose of cabozantinib Estimated creatinine clearance (using Cockcroft-Gault equation) must be > 50 mL/min Has adequate renal function, defined as: Creatinine clearance >= 60 mL/min, as calculated using the modified Cockcroft Gault equation, ([{140 - age in year Serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 40 mL/min within 7 days before the first dose of cabozantinib. For creatinine clearance estimation, the Cockcroft and Gault equation should be used Creatinine clearance >= 60 mL/min/1.73 m^2 (as estimated by Cockcroft Gault equation) for subjects with creatinine levels above institutional normal Creatinine clearance >= 60 mL/min by Cockcroft-Gault equation for participants with creatinine levels above institutional normal, completed within 14 days prior to the date of registration Estimated GFR > 45 ml/min using Cockroft-Gault equation Creatinine clearance >= 45 ml/min (24 hour urine creatinine clearance or calculated by Cockcroft-Gault equation) Calculated creatinine clearance (using Cockcroft-Gault equation) >= 30 mL/min, obtained =< 14 days prior to registration Calculated creatinine clearance ? 30 mL/min (using the Cockcroft-Gault equation). Creatinine clearance (as calculated by Cockroft Gault equation >= 30mL/min Calculated creatinine clearance (CrCl) >= 40 mL/min (based upon the Cockcroft-Gault equation) Creatinine (CR) within the institutional limits of normal or a calculated creatinine clearance of >= 30 mL/min according to the Cockcroft-Gault equation Calculated creatinine clearance >= 30 ml/min (by the Cockcroft-Gault equation) Obtained =< 14 days prior to registration: Calculated creatinine clearance (using Cockcroft-Gault equation) >= 30 mL/min Creatinine clearance (CrCl) >= 30 ml/min (Cockroft-Gault equation) Creatinine clearance >= 60 mL/min by the Cockcroft Gault equation Serum creatinine =< 1.5 x ULN or serum creatinine > 1.5 – 3 x ULN if calculated creatinine clearance (CrCl) is >= 30 mL/min using the Cockroft-Gault equation Serum creatinine =< 1.5 x ULN or estimated creatinine clearance >= 50 mL/min as calculated using the Cockcroft-Gault (CG) equation. Obtained ? 14 days prior to registration: Calculated creatinine clearance (using Cockcroft-Gault equation below) ? 30 mL/min Creatinine clearance >= 30 ml/min based on the Cockcroft-Gault equation. Adequate renal function, as indicated by modified Cockcroft-Gault equation (estimated creatinine clearance [eCCR] with the use of ideal body mass [IBM] instead of mass) Estimated creatinine clearance (CrCL) using the Cockroft-Gault equation ? 50 mL/min Creatinine ? 1.5 x institutional ULN or estimated creatinine clearance of ? 45 mL/min by the Cockcroft-Gault equation or measured creatinine clearance > 45 mL/min Calculated creatinine clearance (CrCl) >= 40 mL/min (based upon the Cockcroft-Gault Equation) Creatinine clearance < 50 mL/min/1.73 m2 by Cockcroft-Gault equation Calculated creatinine clearance >= 60 ml/min (by the Cockcroft-Gault equation) Obtained within 28 days prior to the first dose of cabozantinib: serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 50 mL/min. For creatinine clearance estimation, the Cockcroft and Gault equation should be used. Adequate renal function (The Cockcroft-Gault equation will be used to estimate creatinine clearance. This equation is as follows: Creatinine clearance in ml/min = (140 - age) x body weight (kg)/72 x plasma creatinine (mg/dL); multiplied by 0.85 for women. Using this equation, adequate renal function will be deemed to be a creatinine clearance of greater than 60 ml/minute.) Within 7 days prior to administration of study treatment: Calculated creatinine clearance (Cockcroft-Gault equation) >= 40 mL/min. Creatinine =< 2 mg/dL or creatinine clearance (as estimated by Cockcroft Gault equation) >= 60 mL/min Creatinine clearance >= 30 mL/min based on the Cockcroft-Gault equation Within 7 days before the first dose of study treatment: Serum creatinine =< 1.5 x the ULN or creatinine clearance (CrCl) >= 40 mL/min; for creatinine clearance estimation, the Cockcroft and Gault equation should be used Alanine aminotransferase (ALT) =< 2.5 x ULN; and estimated creatinine clearance (CrCl) of > 30 mL/min, as calculated by the Cockcroft-Gault equation. Obtained =< 14 days prior to registration: Calculated creatinine clearance (using Cockcroft-Gault equation) >= 30 mL/min Creatinine =< 1.5 x institutional ULN or estimated creatinine clearance of >= 45 mL/min by the Cockcroft-Gault equation or measured creatinine clearance > 45 mL/min Serum creatinine =< 2.0 X institutional upper limit of normal or creatinine clearance >= 50 mL/min (according to the Cockroft and Gault equation) Serum creatinine =< 1.5 x ULN or estimated creatinine clearance >= 50 ml/min by Cockcroft-Gault equation Creatinine clearance (calculated per Cockcroft-Gault equation) >= 60 mL/min for participants with creatinine levels above institutional normal Calculated creatinine clearance < 30 ml/min according to Cockcroft-Gault equation Other exclusion criteria included in the protocol might apply. Calculated creatinine clearance >= 30 mL/min using the Cockcroft-Gault equation Creatinine clearance > 50 mL/min/1.73 m^2 by Cockcroft-Gault equation Creatinine clearance > 30 mL/min based on the Cockcroft-Gault equation Participants must have creatinine clearance estimated using the Cockcroft-Gault equation of >= 51 mL/min, measured within 28 days prior to administration of study treatment\r\n* Note: patients with creatinine clearance between 51- 80 mL/min either at trial enrollment or during the course of the trial should be monitored every 2 weeks for laboratory assessment and toxicity evaluation Serum creatinine =< 1.5 x ULN or calculated creatinine clearance >= 60 mL/min (Cockcroft Gault equation) Within 14 days of registration: Creatinine >= 51 mL/min estimated using the Cockcroft-Gault equation Calculated creatinine clearance (using Cockcroft-Gault equation) >= 30 mL/min, obtained =< 14 days prior to registration Estimated creatinine clearance (CrCL) using the Cockcroft-Gault equation >= 50 mL/min Serum creatinine =< 1.5 x ULN or estimated creatinine clearance >= 30 mL/min as calculated using the Cockcroft-Gault (CG) equation Creatinine clearance >= 50 ml/min using a 24 hour creatinine clearance or estimated creatinine clearance using the Cockcroft-Gault equation Creatinine =< 1.5 x ULN, serum creatinine clearance (CL) > 51 ml/min (by the Cockcroft- Gault equation) Serum creatinine =< 1.5 mg/dL or calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault equation Creatinine clearance >= 30 mL/min/1.73 m^2 (as determined by Cockcroft-Gault equation) obtained =< 14 days prior to registration Creatinine clearance < 50 cc/min measured or calculated by Cockroft-Gault equation Calculated creatinine clearance (CCr) >= 50 mL/min/1.73^2 using the Cockcroft-Gault equation Serum creatinine clearance (CrCl) ? 30 mL/min using the Cockcroft- Gault equation Or creatinine clearance ? 60 mL/minute for subjects with serum creatinine outside the normal range (calculated using the Cockcroft-Gault equation). Calculated creatinine clearance (Cockcroft-Gault equation) >= 40 mL/min Calculated creatinine clearance (using Cockcroft-Gault equation) >= 60 mL/min Serum creatinine =< 1.5 mg/dL or creatinine clearance greater or equal than 40 cc/min as defined by the Cockcroft-Gault equation Serum creatinine =< 1.5 mg/dL or creatinine clearance >= 60 mL/min as estimated by the Cockcroft-Gault equation Creatinine > 1.5 times ULN or an estimated creatinine clearance < 50 mL/minute calculated using the Cockcroft-Gault equation Creatinine clearance (CrCl) >= 30 mL/min (as calculated by Cockcroft-Gault equation) Creatinine clearance >= 50 mL/min (by Cockcroft?Gault equation) Creatinine =< 1.5 mg/dL or creatinine clearance > 30 ml/min (estimated as calculated with Cockcroft-Gault equation) Creatinine clearance of < 50 ml/minute by Cockcroft Gault equation Creatinine clearance >= 45 mL/min as calculated by the standard Cockcroft-Gault equation using age, actual weight, creatinine and gender Creatinine clearance greater than or equal to (>=) 60 milliliter per minute (mL/min) either as estimated by the Cockcroft-Gault equation or based on urine collection (12 or 24 hours). Has adequate renal function, defined as: Creatinine clearance >=60 mL/min, as calculated using the modified Cockcroft Gault equation, ([{140 - age in year Within 4 days prior to the first dose of cabozantinib: Serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 50 mL/min (for creatinine clearance estimation, the Cockcroft and Gault equation should be used) Serum creatinine =< 1.5 x ULN or calculated creatinine clearance (CrCl) >= 50 ml/min based upon the Cockcroft-Gault equation Serum creatinine =< 1.5 x ULN OR creatinine clearance (CrCl) >= 40 mL/min; for creatinine clearance estimation, the Cockcroft and Gault equation should be used Patients must have adequate renal function as evidenced by a serum creatinine ? 1.5 X ULN for the reference laboratory OR a calculated creatinine clearance of ? 60 mL/min by the Cockroft-Gault equation. Serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 50 mL/min; for creatinine clearance estimation, the Cockcroft and Gault equation should be used Known chronic liver disease, end stage renal disease, or creatinine clearance < 30 mL/min as defined by Cockcroft-Gault equation Serum creatinine =< 1.5 x ULN or estimated creatinine clearance >= 50 ml/min by Cockcroft-Gault equation Creatinine clearance (CrCL) >= 30 mL/min as calculated by the standard Cockcroft-Gault equation Calculated creatinine clearance (using Cockcroft-Gault equation) >= 30 mL/min obtained =< 14 days prior to registration Obtained =< 14 days prior to registration: Calculated creatinine clearance (using Cockcroft-Gault equation) >= 30 mL/min Creatinine clearance < 40 mL/min calculated by Cockcroft-Gault equation. creatinine clearance < 30 ml /min based on the Cockcroft Gault equation; Cockcroft-Gault equation: creatinine clearance = (140 - age in years) x (wt in kg)) x 1.23) / (serum creatinine in micromol/l) [For women multiply the result of calculation by 0.85]. Patients must have creatinine clearance estimated using the Cockcroft-Gault equation of >= 51 mL/min within 28 days prior to administration of study treatment. Within 28 days prior to administration of study treatment: Patients must have creatinine clearance estimated using the Cockcroft-Gault equation of ? 51 mL/min Creatinine clearance ? 40 mL/min/1.73m^2\r\n* Using 24-hour creatinine clearance or modified Cockcroft-Gault equation Adequate renal function, defined as an estimated creatinine clearance ?30 mL/min using the Cockcroft-Gault equation Estimated creatinine clearance (CrCL) using the Cockcroft-Gault equation >= 50 mL/min RENAL COHORT: Laboratory values as follows within 4 days before the first dose of daratumumab: serum creatinine clearance (CrCl) ? 20 mL/min; dialysis patients will be excluded; for creatinine clearance estimation, the Cockcroft and Gault equation should be used BLADDER: Clinical laboratory values at screening: serum creatinine clearance (CrCl) ? 20 mL/min; dialysis patients will be excluded; for creatinine clearance estimation, the Cockcroft and Gault equation should be used Within 7 days before the first dose of cabozantinib: Serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 40 mL/min; for creatinine clearance estimation, the Cockcroft and Gault equation should be used Creatinine clearance of >= 40 mL/min, estimated or calculated using the Cockcroft-Gault equation. Estimated creatinine clearance > 50 mL/min by Cockcroft-Gault equation Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance > 30 mL/min based on the Cockroft-Gault equation Creatinine clearance estimated using the Cockcroft-Gault equation of >= 51 mL/min. Creatinine (Cr) Clearance >= 25 mL/min (per Cockcroft-Gault equation). Creatinine clearance >= 50 ml/mm (can be calculated utilizing the Cockcroft & Gault equation) Calculated creatinine clearance of >= 30 mL/min according to Cockcroft-Gault equation Calculated creatinine clearance according to the Cockcroft and Gault equation >= 50 mL/min Subject has adequate renal function: serum creatinine ? 2.0 mg/dL and estimated creatinine clearance of ? 30 mL/min by the Cockcroft-Gault equation Measured within 28 days prior to administration of study treatment: Creatinine clearance estimated using the Cockcroft-Gault equation of >= 51 mL/min Obtained =< 7 days prior to registration: Creatinine clearance >= 30 mL/min (as determined by Cockcroft-Gault equation) Creatinine ?1.5 mg/dL OR estimated creatinine clearance ?60 mL/min calculated using Cockcroft-Gault equation Serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 50 mL/min; for creatinine clearance estimation, the Cockcroft and Gault equation should be used Creatinine clearance >= 60 mL/min by the Cockcroft-Gault equation Calculated creatinine clearance (using Cockcroft-Gault equation) >= 30 mL/min Creatinine clearance >= 60 mL/min, as calculated by Cockcroft-Gault equation Creatinine clearance (CrCl) >= 50 mL/min; for creatinine clearance estimation, the Cockcroft and Gault equation should be used Part B: Renal function, as follows: creatinine clearance estimate ? 15 mL/min and <60 mL/min by cockroft gault equation adjusted for body weight Creatinine =< 1.5 upper limit of normal (ULN) AND creatinine clearance (CrCl) > 50 mL/min by Cockcroft-Gault equation Creatinine level < 1.0 x ULN or creatinine clearance ? 60 mL/min/1.73 m^2 for patients with creatinine levels above or below the institutional normal (as determined by Cockcroft-Gault equation). For patients with a Body Mass Index (BMI) > 30 kg/m^2, lean body weight should be used to calculate the GFR. Serum creatinine ? ULN (with value applied to Cockcroft-Gault equation) or 24 hour clearance ? 50mL/min. Have a calculated serum creatinine clearance greater than or equal to 45 mL/min using the Cockcroft-Gault equation Estimated creatinine clearance (CrCl) of > 30 mL/min, as calculated by the Cockcroft-Gault equation unless disease related Calculated creatinine clearance (eGFR) < 60 ml/min; EGFR values can be determined by either MDRD or Cockcroft-Gault equation based on the investigator’s discretion Have a calculated creatinine clearance (Cockroft-Gault equation) > 50 mL/min Calculated creatinine clearance (CrCl) >= 40 mL/min (based upon the Cockcroft-Gault equation) Creatinine must be < 1.5 ULN or creatinine clearance must be > 50 mL/min (calculated by Cockcroft and Gault equation) Calculated creatinine clearance of > 50 mL/min using the Cockcroft-Gault equation for adult patients 18 to 70 years old based on ideal body weight, and the Schwartz equation for pediatric patients 6 months to 17 years old Calculated creatinine clearance >= 30 mL/min using the Cockcroft-Gault equation Renal function: serum creatinine ? 2.0 mg/dL and estimated creatinine clearance of ? 45 mL/min by the Cockcroft-Gault equation Calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault equation Creatinine ?1.5 x ULN or creatinine clearance >60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal (as determined by Cockcroft-Gault equation). Creatinine >1.5 x ULN concurrent with creatinine clearance <50 mL/min (measured or calculated by Cockcroft and Gault equation); confirmation of creatinine clearance is only required when creatinine is >1.5 x ULN Patients must have creatinine clearance estimated using the Cockcroft-Gault equation of >= 51 mL/min. Creatinine =< 1.5 institutional ULN or a calculated creatinine clearance >= 50 mL/min using the Cockcroft Gault equation Serum creatinine within normal institutional limits or estimated creatinine clearance >= 60 mL/min/1.73 m^2 by the Cockcroft-Gault equation Creatinine clearance >= 30 ml/min (as estimated by Cockcroft Gault equation) Estimated creatinine clearance by Cockcroft-Gault equation > 30 mL/min Estimated creatinine clearance by Cockcroft-Gault equation > 30 mL/min Creatinine clearance (CLcr) < 30 ml/min (estimated creatinine clearance by the Cockcroft-Gault (C-G) equation) . creatinine clearance >60 mL/min/ per Cockcroft-Gault equation for patients with creatinine levels above institutional normal. Within one week of study entry: Creatinine clearance >= 30 ml/min (as estimated by Cockroft Gault equation) Serum creatinine =< 1.5 X ULN or creatinine clearance >= 50 mL/min; for creatinine clearance estimation, the Cockcroft and Gault equation should be used Serum creatinine =< 1.5 mg/dl OR creatinine clearance >= 30 ml/min (as estimated by Cockroft Gault equation) Calculated creatinine clearance (using Cockcroft-Gault equation) >= 30 mL/min (obtained =< 14 days prior to registration) Creatine clearance < 55 mL/min, calculated using ideal body weight (IBW) using Cockcroft-Gault equation Creatinine clearance of ? 60 mL/min as estimated by the Cockcroft-Gault equation Inadequate renal function at screening as demonstrated by creatinine clearance < 40 mL/min calculated by Cockcroft-Gault equation. Serum creatinine < 1.8 mg/dL or creatinine clearance greater or equal than 40 cc/min as defined by the Cockcroft-Gault equation Creatinine ? 1.5× ULN; or, if serum creatinine > 1.5 × ULN, a measured creatinine clearance must be >60mL/min/1.73m2 as calculated by the Cockcroft and Gault equation for patient to be eligible. Calculated creatinine clearance greater than 50 ml/min; using the Cockcroft-Gault equation Creatinine =< 1.5 mg/dL or calculated creatinine clearance (CrCL) >= 50 mL/min using the Cockroft Gault equation Serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 50 mL/min; for creatinine clearance estimation, the Cockcroft and Gault equation should be used Serum creatinine =< 1.5 mg/dl and calculated creatinine clearance >= 50 mL/min (using the Cockcroft-Gault equation) Serum creatinine =<1.5 mg/dl OR creatinine clearance >= 30 ml/min (as estimated by Cockroft Gault equation) Creatinine clearance >= 60 mg/dL (Cockcroft-Gault equation) Creatinine ? 1.5 × institutional ULN or Creatinine Clearance > 50 ml/min (as calculated by the Cockroft-Gault equation) within 14 days prior to randomization. Calculated creatinine clearance < 30 ml/min according to Cockcroft-Gault equation Serum creatinine clearance (Cockcroft-Gault equation) >= 50 mL/minute Estimated creatinine clearance (CLcr) ? 60 mL/min as calculated using the Cockcroft-Gault equation CLcr 15-29 mL/min as calculated using the Cockcroft-Gault equation Serum creatinine =< 1.5 x ULN or serum creatinine > 1.5-3 x ULN if calculated creatinine clearance (CrCl) is >= 30 mL/min using the Cockroft-Gault equation Serum creatinine =< 1.5 x ULN, or creatinine clearance (CrCl) >= 30 mL/min; for creatinine clearance estimation, the Cockcroft and Gault equation should be used Serum creatinine ? 1.5 × upper limit of normal (ULN) or calculated creatinine clearance ? 60 mL/min using Cockcroft-Gault equation Creatinine clearance >= 60 mL/min (1.00 mL/s) calculated by the Cockcroft-Gault equation for women Creatinine =< 1.5 mg/dL or calculated creatinine clearance (CrCL) >= 50 mL/min using the Cockroft Gault equation Calculated creatinine clearance (CrCl) >= 30 mL/min using the Cockroft Gault equation Serum creatinine =< 1.5 x ULN or estimated creatinine clearance >= 60 mL/min by the Cockcroft-Gault equation Calculated creatinine clearance* >= 60 ml/min\r\n* Using the Cockcroft-Gault equation Renal: serum creatinine >=60 milliliter per minute (mL/min) either as estimated by the Cockcroft-Gault equation or based on urine collection (12 or 24 hours). Creatinine clearance >= 30 mL/min as calculated by Cockcroft-Gault equation (obtained within 28 days prior to the first study treatment) Creatinine =< 1.5 mg/dL is recommended; however, institutional norms are acceptable; creatinine within institutional limits of normal or creatinine clearance (CrCl) > 50 mL/min calculated using the Cockcroft-Gault equation Adequate renal function defined as: a. Creatinine clearance >50 mL/min, as calculated with the modified Cockcroft Gault equation Serum creatinine =< 1.5 x ULN or calculated creatinine clearance >= 40 mL/min (using the Cockcroft-Gault equation) Calculated creatinine clearance of > 50 mL/min using Cockcroft Gault equation equation or 24-hour urine sampling Arm C: Calculated creatinine clearance(CrCl) > 50 ml/min using the Cockcroft-Gault equation eGFR > 40 mL/min using the Cockcroft-Gault equation Creatinine clearance >50 mL/min/1.73 m2 based on Cockcroft Gault equation. - Serum Cr < 1.5 x ULN or estimated GFR > 60 ml/min based upon Cockroft-Gault equation Creatinine < 1.5 x upper limit of normal (ULN) or estimated creatinine clearance >= 50 mL/min (by the Cockcroft Gault equation) Creatinine < 1.5 x upper limit of normal (ULN) or estimated creatinine clearance >= 50 mL/min (by the Cockcroft Gault equation) Renal dysfunction as defined as creatinine clearance < 70 mL/min by Cockcroft-Gault equation HEALTHY VOLUNTEER: An estimated creatinine clearance of =< 80 ml/min based on the Cockcroft-Gault equation; an actual creatinine clearance, as determined by a 24 hour urine collection, may be used in place of the Cockcroft-Gault equation; subjects who have an actual or estimated creatinine clearance 70 ml/min may be enrolled at the discretion of the investigator Estimated creatinine clearance >= 50 mL/min (by the Cockcroft Gault equation) Serum creatinine =< 1.5 x upper limit of normal (ULN) or calculated creatinine clearance (CrCl) >= 50 mL/min as determined by the Cockcroft-Gault equation Estimated creatinine clearance by the Cockcroft Gault equation >= 50 mL/min - Serum Cr < 1.5 x ULN or estimated GFR > 60 ml/min based upon Cockroft-Gault equation Renal: serum creatinine <=1.5*ULN or creatinine clearance >=60 milliliter per minute (mL/min) as estimated by the Cockcroft-Gault equation or based on urine collection (12 or 24 hours). Estimated serum creatinine clearance of ? 60 mL/min using the Cockcroft-Gault equation. Creatinine clearance must be greater than or equal to (>=) 60 milliliter per (mL/) minute as estimated by the Cockcroft Gault equation or based on urine collection (12 or 24 hours). Serum creatinine =< 1.5 x ULN OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal (calculated with the Cockcroft-Gault Equation in EPIC) Serum creatinine < 1.5 times institutional upper limit of normal OR calculated creatinine clearance (CrCl) >= 40 mL/min (based upon the Cockcroft-Gault equation) Measured creatinine clearance (CL) > 40 mL/min OR calculated creatinine clearance (CL) > 40 mL/min as determined by Cockcroft-Gault (using actual body weight) Creatinine clearance of > 60 ml/min; creatinine clearance may be measured or calculated; if calculating, creatinine clearance, use the Cockroft-Gault formula =< 2 weeks prior to randomization Creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault OR creatinine < 1.5 x ULN, within 2 weeks of randomization Calculated creatinine clearance of > 50 mL/min using the Cockcroft-Gault formula, must be obtained within 8 weeks prior to screening for protocol therapy ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Calculated creatinine clearance of > 50 mL/min using the Cockcroft-Gault formula Serum creatinine =< the IULN OR measured or calculated creatinine clearance >= 50 mL/min using the following Cockcroft-Gault Formula within 28 days prior to sub-study registration Re-registration: creatinine =< 1.5 ULN OR calc. creatinine clearance > 45 mL/min (using lean body mass formula only) Serum creatinine =< 1.5 x ULN or calculated creatinine clearance > 50 mL/min (using the Cockcroft-Gault formula) must be obtained =< 7 days prior to protocol registration Within 2 weeks prior to registration: Creatinine =< 1.5 x ULN or calculated (Cockcroft-Gault formula) or measured creatinine clearance >= 50 mL/min/1.73 m^2 (normalized to body surface area [BSA]) for patients with creatinine levels greater than 1.5 times the institutional normal Calculated creatinine clearance must be > 60 ml/min using the Cockcroft-Gault formula within 4 weeks prior to randomization Within 10 days of treatment initiation: Measured or calculated creatinine clearance >= 50 mL/min\r\n* Creatinine clearance should be calculated using modified Cockcroft-Gault equation (using ideal body mass [IBM] instead of mass). Direct measured creatinine clearance (i.e. 24h urine or other method) can be substituted if calculated creatinine clearance is thought to be inadequate per treating physician Calculated creatinine clearance using cockroft Gault formula >/= 50 mL/min (see Appendix 1) Serum creatinine =< 1.5 x upper limit of normal (ULN) or calculated creatinine clearance using Cockcroft-Gault formula >= 50 mL/min Serum creatinine =< 1.5 x upper limit of normal (ULN) OR, for subjects with creatinine levels > 1.5 x ULN, an estimated creatinine clearance of >= 40 mL/min calculated using the Cockcroft and Gault formula must be met within 28 days of C1D1 Obtained =< 14 days prior to registration: Calculated creatinine clearance >= 45 ml/min using the Cockcroft-Gault formula Creatinine =< 1.5 ULN or calculated creatinine clearance* >= 50 mL/min\r\n* Calculate creatinine clearance using standard Cockcroft-Gault formula; creatinine clearance must be >= 50 mL/min to be eligible Creatinine < 1.5 x ULN or creatinine clearance > 60 ml/min according to Cockcroft-Gault formula Calculated or measured creatinine clearance of >= 30 mL/minute calculated using the Cockcroft and Gault formula Serum creatinine ? 1.5 X upper limit of normal (ULN) OR calculated clearance ? 50 mL/min/1.73 m^2; if using creatinine clearance, actual body weight should be used for calculating creatinine clearance (e.g., using the Cockcroft-Gault formula); for subjects with a body mass index (BMI) > 30 kg/m^2, lean body weight should be used instead Serum creatinine =< 1.5 x institutional ULN OR creatinine clearance >= 50 mL/min/1.73 m^2 by Cockcroft-Gault Creatinine clearance > 60 Ml/min/1.73 m2 for patients with creatinine levels above ULN calculated using Calvert formula Creatinine =< 1.5 x institutional upper limit of normal OR creatinine clearance >= 50 mL/min as determined by the Cockcroft-Gault formula EXPANDED ACCESS COHORT: Creatinine clearance >= 50 mL/min (determined by the Cockcroft-Gault method) for participants with creatinine levels above 1.5 x institutional ULN Obtained within 28 days prior to registration: Calculated creatinine clearance >= 60 cc/min (Cockcroft-Gault formula will be used to calculate creatinine clearance) Serum creatinine within normal limits or calculated clearance > 60 mL/min/1.73 m^2 for patients with serum creatinine levels above or below the institutional normal value. If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (eg. Using the Cockcroft-Gault formula). For patients with a Body Mass Index (BMI) > 30 kg/m^2, lean body weight should be used instead. Creatinine =< 1.5 times upper limit of normal OR calculated creatinine clearance > 45 mL/min\r\n* Using the lean body mass formula only (Modified Cockcroft Gault) Creatinine clearance ? 50 mL/min; the serum creatinine value used in the calculation must have been obtained within 28 days prior to registration using the modified Cockcroft-Gault formula Calculated creatinine clearance >= 50 ml/min using the Cockcroft-Gault formula Calculated creatinine clearance (using Cockcroft-Gault formula) > 45 mL/min, at the screening visit Calculated creatinine clearance >= 30 mL/min using Cockcroft-Gault formula Estimated creatinine clearance of >= 40 mL/min/1.73 m^2, calculated using the Cockcroft-Gault equation for adults and Schwartz formula for pediatric patients, for patients with creatinine levels above the institutional upper limit of normal Serum creatinine =< 1.5 x ULN or calculated creatinine clearance >= 50 ml/min (by Cockroft-Gault formula) Creatinine ?1.5 x ULN or creatinine clearance ?40 mL/min as calculated by the Cockcroft-Gault method Serum creatinine < 1.5 x upper limit of normal (ULN) or calculated creatinine clearance of >= 45 cc/min using the Cockcroft-Gault formula Creatinine clearance >= 50 mL/min/1.73 m^2 for patients with creatinine levels above 1.5 x institutional normal (using the Cockcroft Gault formula) Serum creatinine =< 1.5 times institutional upper limit of normal (ULN), or calculated creatinine clearance >= 40 mL/min (per the Cockcroft-Gault formula) within 14 days prior to first dose of protocol-indicated treatment. Creatinine clearance >= 51 mL/min (calculated using the Cockcroft-Gault formula), =< 5 days prior to C1D1 Calculated creatinine clearance >= 40 mL/min using the Cockcroft-Gault formula obtained within 14 days prior to initiating study treatment. Calculated creatinine clearance > 40 mL/min as determined by Cockcroft-Gault (using actual body weight). Serum creatinine < 1.5 x ULN or measured creatinine clearance (calculated using Cockcroft-Gault formula) > 40 ml/min Cockcroft-Gault calculated creatinine clearance of >= 45 ml/min or creatinine =< 1.5 x ULN obtained =< 14 days prior to study initiation Serum creatinine =< 1.5 X institutional ULN or creatinine clearance > 40 ml/min as calculated by the Cockcroft-Gault formula Within 28 days prior to administration of study treatment: Creatinine clearance >= 51 mL/min, calculated using Cockcroft-Gault formula Serum creatinine =< 1.5 x the upper limit of normal (ULN) or calculated creatinine clearance (by Cockcroft-Gault formula) >= 60 mL/min Creatinine > 1.5 x within normal institutional ULN OR creatinine clearance >= 40 mL/min (using Cockcroft-Gault formula) for participants with creatinine levels above institutional ULN Obtained =< 14 days prior to registration: Calculated creatinine clearance must be >= 45 ml/min using the Cockcroft-Gault formula Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance > 40 mL/min (if using the Cockcroft-Gault formula) within 14 days of registration Calculated creatinine clearance >= 30 mL/min using the Cockcroft-Gault formula for subjects with creatinine levels > 2.0 x institutional ULN (obtained within three days prior to study treatment) Calculated creatinine clearance of >= 60 cc/min using the Cockcroft-Gault formula Serum creatinine =< 2 x upper limit of normal (ULN) or estimated creatinine clearance >/=30 ml/min as calculated using the Cockcroft-Gault formula. Creatinine ?1.5 times the ULN and calculated creatinine clearance >60 mL/min (by Cockcroft Gault formula; see Appendix B); Serum creatinine ? 1.5 times the ULN or creatinine clearance > 30 mL/min by Cockcroft-Gault formula Creatinine =< 1.5 x ULN or calculated creatinine clearance >= 50 mL/min using Cockcroft-Gault formula for creatinine clearance calculation OR 24-hour urine creatinine clearance >= 50 mL/min Calculated creatinine clearance >= 50 ml/min (using Cockcroft-Gault method) Within 14 days prior to cycle 1 day 1 of treatment: Serum creatinine < 2.0 or >= 30 cc/min using a direct method or the Cockcroft-Gault formula Creatinine clearance > 30 mL/min (calculated according to institutional standards or using Cockcroft–Gault formula) Serum creatinine =< 2 x upper limit of normal (ULN) or creatinine clearance (calculated with the Cockcroft-Gault formula) >= 30 mL/min, within 30 days before study registration Serum creatinine =< 1.5 x ULN or creatinine clearance (calculated with the Cockcroft-Gault formula) >= 40 mL/min, within 30 days before study registration Acceptable renal function within 7 days defined as serum creatinine ? 2.0 times the institutional upper limit of normal (ULN) or calculated creatinine clearance ? 50 mL/min (by the Cockcroft Gault formula). Calculated creatinine clearance must be >= 45 ml/min using the Cockcroft-Gault formula obtained =< 7 days prior to registration Creatinine within normal institutional limits OR creatinine clearance > 60 mL/min/1.73 m^2 by Cockcroft-Gault formula Serum creatinine =< 1.5 x upper limit of normal (ULN) OR calculated creatinine clearance >= 40 mL/min (obtained within 28 days prior to first study treatment)\r\n* Cockcroft-Gault formula will be used to calculate creatinine clearance Creatinine =< 1.5 x ULN OR creatinine clearance >= 50 mL/min calculated using the formula of Cockcroft and Gault Creatinine clearance >= 40 mL/min for patients with creatinine\r\n* Levels above institutional normal (calculated using the Cockcroft-Gault formula) Creatinine clearance (calculated creatinine clearance by Cockroft-Gault using adjusted body weight if actual body weight is 20% greater than ideal is permitted) should be > 50 ml/min Obtained =< 14 days prior to randomization: Calculated creatinine clearance must be >= 45 ml/min using the Cockcroft-Gault formula Creatinine =< 1.5 x ULN or creatinine clearance > 50 mL/min (calculated by Cockcroft-Gault method) Serum creatinine >= 1.5 x upper limit of normal (ULN) and creatinine clearance (by Cockcroft-Gault formula) < 60 mL/min Creatinine within normal institutional limits OR creatinine clearance > 60 mL/min/1.73 m^2 by Cockcroft-Gault formula PHASE I: Creatinine =< ULN OR creatinine clearance >= 51 mL/min (calculated using the Cockcroft-Gault formula) for patients with creatinine levels above institutional normal PHASE II SCLC: Creatinine =< ULN OR creatinine clearance >= 51 mL/min (calculated using the Cockcroft-Gault formula) for patients with creatinine levels above institutional normal UROTHELIAL CARCINOMA EXPANSION COHORT: Creatinine =< ULN OR creatinine clearance >= 51 mL/min (calculated using the Cockcroft-Gault formula) for patients with creatinine levels above institutional normal mCRPC EXPANSION COHORT: Creatinine =< ULN OR creatinine clearance >= 51 mL/min (calculated using the Cockcroft-Gault formula) for patients with creatinine levels above institutional normal Serum creatinine < 1.5 x ULN or creatinine clearance > 50 mL/min (by Cockcroft- Gault) plasma creatinine ? 1.5 x upper limit of normal (ULN) for the institution or calculated clearance ? 60 mL/min (Cockcroft-Gault formula) Creatinine within normal institutional limits OR creatinine clearance >= 50 mL/min based on the standard Cockcroft and Gault formula obtained within 14 days of first treatment Creatinine level within normal institutional limit, or creatinine clearance > 15 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal, calculated using the Cockcroft-Gault formula) Within 14 days prior to study entry: Calculated creatinine clearance >= 40 mL/min using Cockcroft-Gault formula Creatinine =< 1.5 x ULN OR calculated creatinine clearance >= 60 mL/min calculated by the Cockcroft-Gault formula ARM A COHORT 1: Creatinine =< 1.5 x institutional ULN, or creatinine clearance >= 50 mL/min (calculated with the Cockcroft-Gault formula) ARM B COHORT 2: Creatinine =< 1.5 x institutional ULN, or creatinine clearance >= 50 mL/min (calculated with the Cockcroft-Gault formula) ARM B COHORT 3: Creatinine =< 1.5 x institutional ULN, or creatinine clearance >= 50 mL/min (calculated with the Cockcroft-Gault formula) ARM C COHORT 4: Creatinine =< 1.5 x institutional ULN, or creatinine clearance >= 50 mL/min (calculated with the Cockcroft-Gault formula) Serum creatinine =< 1.5 times the upper limit of normal or creatinine clearance > 30 mL/min by Cockcroft-Gault formula Calculated creatinine clearance must be >= 50 ml/min using the Cockcroft-Gault formula 24 hour creatinine clearance or calculated (using the Cockcroft-Gault formula) creatinine clearance > 60 mL/min/1.73 m^2 (induction phase only) RESEARCH PHASE INCLUSION CRITERIA: 24 hour creatinine clearance or calculated (using the Cockcroft-Gault formula) creatinine clearance > 60 mL/min/1.73 m^2 (induction phase only) Must be met within 28 days of C1D1: Serum creatinine =< 1.5 x ULN or estimated creatinine clearance of >= 40 mL/min calculated using the formula of Cockcroft and Gault Creatinine clearance > 30 mL/min (calculated according to institutional standards or using Cockcroft–Gault formula; subjects with requirement of hemodialysis will be excluded) Creatinine =< 1.5 x ULN OR creatinine clearance >= 50 mL/min calculated using the formula of Cockcroft and Gault PART 2: Calculated creatinine clearance using the Cockcroft-Gault formula or 24 hr urine creatinine clearance must be > 60 ml/min Creatinine > 1.5 times the upper limit of normal (ULN) (unless creatinine clearance normal), or calculated creatinine clearance < 40 mL/min (using Cockcroft-Gault formula) Patients must have a serum creatinine ? the institutional upper limit of normal OR a creatinine clearance ? 60 cc/min, measured or calculated (Cockcroft-Gault formula), obtained within 14 days prior to registration. Creatinine within normal institutional limits OR creatinine clearance >= 50 mL/min/1.73 m^2 by Cockcroft-Gault formula Serum creatinine ? 1.5 x ULN and/or creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 50 mL/min Calculated creatinine clearance of >= 50 cc/min using the Cockcroft-Gault formula Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 45 mL/min Calculated creatinine clearance of >= 55 cc/min using the Cockcroft-Gault formula Renal: serum creatinine within normal limits; for patients with levels above the institutional normal value, the calculated corrected creatinine clearance must be ? 60 mL/min/1.73 m^2 using the Cockcroft-Gault formula corrected for the body surface area. Within 14 days prior to randomization: Serum creatinine =< 1.5 x ULN or measured or calculated creatinine clearance >= 50 mL/min using the Cockroft-Gault formula for patients with creatinine levels > 1.5 x ULN for the lab Creatinine clearance >= 50 mL/min (using Cockcroft-Gault) Obtained ? 14 days prior to registration: calculated creatinine clearance must be ? 30 ml/min using the Cockcroft Gault formula Creatinine ? 1.5 x upper limits of normal (ULN) OR calculated creatinine clearance ? 60 mL/min by Cockcroft-Gault formula Serum creatinine performed within 3 weeks prior to starting study therapy must be =< 1.5 x ULN, or have calculated creatinine clearance (using Cockcroft-Gault formula) of >= 50 mL/minute Calculated creatinine clearance must be >= 30 ml/min using the Cockcroft-Gault formula To be performed within 28 days prior to day 1 of protocol therapy: Creatinine < 1.5 x ULN or creatinine clearance of >= 60 mL/min per the Cockcroft-Gault formula Creatinine clearance >= 50; creatinine clearance must be calculated using Cockroft-Gault formula Calculated creatinine clearance must be >= 50 ml/min using the Cockcroft-Gault formula, obtained =< 14 days prior to registration Obtained within 30 days prior to registration: Estimated creatinine clearance 40 cc/min OR serum creatinine =< 1.5 x upper limit of normal (ULN)\r\n* Cockcroft-Gault formula will be used to calculate creatinine clearance Serum creatinine =< 1.5 x institutional ULN (Cockcroft and Gault formula) Creatinine clearance >= 60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal (derived by the Cockcroft-Gault formula) Serum creatinine =< ULN or calculated creatinine clearance >= 35 mL/min using Cockcroft-Gault formula Creatinine =< 1.5 x ULN OR calculated creatinine clearance >= 50 ml/min using the Cockcroft-Gault formula (obtained =< 14 days prior to registration) Patients must have a serum creatinine =< the IULN OR measured or calculated creatinine clearance >= 50 mL/min using the Cockroft-Gault formula Creatinine clearance > 30 cc/min calculated using the Cockcroft and Gault (1976) formula or measured Creatinine =< 1.5 ULN or calculated creatinine clearance >= 50 mL/min or 24-hour urine creatinine clearance >= 50 mL/min; calculated by the Cockcroft-Gault formula Creatinine =< 1.5 x institutional/laboratory upper limit of normal (ULN) OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 ml/min OR 24-hour urine creatinine clearance >= 50 ml/min Creatinine =< 1.5 times the upper limit of normal with creatinine clearance >= 50 mL/min using the modified Cockcroft-Gault method Creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above ULN as calculated by Cockcroft-Gault For patients receiving chemotherapy:\r\n* Within 14 days prior to registration, serum creatinine =< 1.5 mg/dL and calculated creatinine clearance >= 50 cc/min; both tests must be within these limits; the creatinine clearance should be calculated using the Cockcroft-Gault formula\r\n* Aspartate aminotransferase (AST) =< 2 times upper limit of normal (ULN)\r\n* Bilirubin =< 2 times ULN\r\n* Alkaline phosphatase, magnesium, blood urea nitrogen (BUN), and electrolytes must be obtained and recorded Creatinine =< grade 1 OR creatinine clearance >= 40 mL/min/1.73 m^2 for patients with creatinine (Cr) above normal institutional limits; a calculated creatinine clearance by Cockcroft-Gault Formula is acceptable in lieu of a measured value Calculated creatinine clearance >= 60 mL/min; the serum creatinine value used in the calculation must have been obtained within 28 days prior to registration; use the modified Cockcroft-Gault formula Creatinine clearance < 30 ml/min within 21 days of initiation of protocol therapy; creatinine clearance will be the primary eligibility criteria in determining renal insufficiency; the Cockcroft-Gault formula should be used for calculating creatinine clearance values Creatinine =< ULN (Common Toxicity Criteria [CTC] grade 0) OR calculated creatinine clearance (Cockcroft-Gault formula) >= 60 mL/min OR >= 50 mL/min by ethylenediaminetetraacetic acid (EDTA) creatinine clearance Serum creatinine levels <= 1.5 * ULN, or calculated (by Cockcroft-Gault formula or other accepted formula) or measure creatinine clearance >=50 mL/min. Patients must have a serum creatinine =< the IULN AND measured or calculated creatinine clearance >= 60 cc/min using the Cockroft-Gault formula REGISTRATION #2 - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Patients must have a serum creatinine =< (IULN) AND measured of calculated creatinine clearance >= 60 cc/min using the Cockroft-Gault formula Patients must have a serum creatinine =< the IULN OR measured or calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault formula Serum creatinine level ? ULN or creatinine clearance ? 50 ml/min for patients with creatinine levels above normal limits (creatinine clearance calculated by the Cockcroft-Gault formula, see Appendix II), Calculated creatinine clearance < 45mL/min (0.75 mL/sec)using Cockroft-Gault formula Calculated creatinine clearance must be >= 50 ml/min using the Cockcroft-Gault formula obtained =< 7 days prior to registration Serum creatinine > 1.5 x upper limit of normal (ULN) and/or creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 50 mL/min Serum creatinine ?1.5 x upper limit of normal or creatinine clearance >60 mL/min (measured or calculated by the Cockcroft-Gault formula) (Cockcroft DW et al, 1976). Calculated creatinine clearance must be >= 50 ml/min using the Cockcroft-Gault formula or a 24 hour urine obtained =< 7 days prior to randomization Creatinine clearance > 30 cc/min calculated using the Cockcroft and Gault (1976) formula or measured Serum creatinine, ? 1.5x Institutional Upper Limit of Normal (ULN), or Creatinine Clearance ? 50 mL/min (by Cockcroft-Gault formula) Creatinine clearance > 50 ml/min, calculated using the formula of Cockcroft and Gault Serum creatinine ? 1.5 x ULN or calculated creatinine clearance (using Cockcroft and Gault method) > 60 mL/min) Serum creatinine =< 1.5 x ULN; or calculated creatinine clearance >= 50 mL/min (using Cockcroft Gault formula); or measured creatinine clearance >= 50 mL/min Creatinine clearance > 30 mL/min (calculated according to institutional standards or using Cockcroft–Gault formula; subjects with requirement of hemodialysis will be excluded) Calculated creatinine clearance must be >= 45 ml/min using the Cockcroft-Gault formula Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance of >= 40 mL/min by Cockcroft-Gault formula Creatinine clearance > 50 mL/minute within 7 days of time of consent, either measured or calculated using a standard formula (e.g., Cockcroft and Gault) Calculated creatinine clearance must be > 60 ml/min using the Cockcroft-Gault formula Creatinine clearance of ? 50 mL/min (measured or calculated using the Cockcroft and Gault formula) Calculated or measured creatinine clearance of >= 50 mL/minute, calculated using the formula of Cockcroft and Gault Creatinine =< 1.5 x ULN or calculated creatinine clearance >= 50 mL/min calculated by the Cockcroft-Gault formula or 24-hour urine creatinine clearance >= 50 mL/min Cockcroft-Gault calculated creatinine clearance of >= 45 ml/min or creatinine =< 1.5 x ULN obtained =< 14 days prior to randomization Serum creatinine >1.5x ULN or creatinine clearance <40 mL/min (Cockroft-Gault formula) Exclusion Criteria for Arm S and Arm P only: Creatinine clearance >= 30 mL/min as measured using either the Cockcroft-Gault method or 24-hour creatinine clearance Calculated creatinine clearance > 50 ml/min using Cockcroft-Gault formula All patients must: Have biopsy proven cancer (i.e. solid tumor) for which there is no standard therapy available. If prior history of ischemic heart disease or exposure to > 200 mg/m^2 of doxorubicin, patients must have a measured ejection fraction (either by MUGA, ECHO or ventriculography) of at least 45%. Have preserved hepatic function as shown by AST (SGOT) levels < 2 x the upper limit of normal and an INR (for patients NOT on anticoagulant therapy) of < 1.4. Have normal serum creatinine (<=1.5) or creatinine clearance (measured by Cockcroft -Gault formula) of >= 20 ml/min. Creatinine within normal institutional limits OR creatinine clearance >= 30 mL/min calculated using the formula of Cockcroft and Gault Creatinine clearance > 30 ml/min (Cockcroft-Gault formula using ideal body weight) Serum creatinine within normal limits or calculated clearance ? 50 mL/min/1.73 m2 for subjects with serum creatinine levels above or below the institutional normal value. If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (eg, using the Cockroft-Gault formula). For subjects with a body mass index (BMI) > 30 kg/m2, lean body weight should be used instead. Serum creatinine =< 1.5 x the ULN or calculated creatinine clearance >= 50 ml/min using Cockcroft-Gault formula Serum creatinine =< 1.5 x ULN or 24-hour creatinine clearance > 60 mL/min (measured or calculated by Cockcroft-Gault method) Serum creatinine ?1.5 x upper limit of normal (ULN) or creatinine clearance >60 mL/min calculated using Cockcroft-Gault Creatinine clearance >/=30 milliliters per minute (mL/min) (calculated using the Cockcroft-Gault formula) Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance > 40 ml/min using the Cockcroft-Gault formula should be obtained with 28 days prior to randomization Plasma creatinine =< 1.5 x ULN or creatinine clearance > 50 mL/min (calculated by Cockcroft-Gault method) Creatinine < 1 X institutional upper limit of normal OR creatinine clearance >= 50 mL/min determined by Cockcroft-Gault formula Creatinine clearance > 30 mL/min (calculated according to institutional standards or using Cockcroft–Gault formula), +/- 7 days from date of ICF signing Calculated creatinine clearance must be >= 50 ml/min using the Cockcroft-Gault formula Serum creatinine =< 1.5 x upper limit of normal (ULN) or calculated creatinine clearance >= 60 cc/min using the Cockcroft-Gault formula Calculated creatinine clearance must be >= 50 ml/min using the applicable Cockcroft-Gault formula Creatinine* < 2.0 g/dl *or a calculated creatinine clearance > 45/cc (using Cockroft-Gault formula) Calculated creatinine clearance ? 45 mL using the Cockcroft and Gault Method Serum creatinine =< 1.5 x ULN OR creatinine clearance >= 50 mL/min (Cockcroft-Gault calculation) Renal impairment as determined by a creatinine clearance < 60 ml/min as calculated by the Cockcroft-Gault formula using the patient's actual weight Creatinine clearance > 15 ml/minute using Cockcroft-Gault formula Creatinine clearance 45 ml/min or higher calculated using the Cockcroft-Gault formula Creatinine clearance >= 30 mL/min calculated using the Cockcroft-Gault formula (within four weeks prior to the study) Calculated (e.g. using Cockcroft-Gault formula) or measured creatinine clearance < 50 ml/min Calculated creatinine clearance >= 50 ml/min by Cockcroft-Gault formula using actual body weight Calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault formula Calculated (calc.) creatinine clearance >= 60 mL/min calculated using the Cockcroft-Gault formula Calculated creatinine clearance > 40 ml/min using Cockcroft-Gault method Obtained =< 30 days prior to randomization: Calculated creatinine clearance must be >= 30 ml/min using the Cockcroft-Gault formula Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min using the modified Cockcroft-Gault formula Calculated creatinine clearance must be >= 30 ml/min using the Cockcroft-Gault formula obtained =< 30 days prior to registration Obtained within 28 days prior to registration: Serum creatinine =< 1.5 x upper limit of normal (ULN) OR calculated creatinine clearance >= 40 mL/min (Cockcroft-Gault formula will be used to calculate creatinine clearance) Creatinine =< 1.5 times the upper limit of normal with creatinine clearance >= 50 mL/min using the modified Cockcroft-Gault method Serum creatinine =< 1.5 x ULN or measured calculated creatinine clearance >= 40 ml/min for subject with creatinine levels > 1.5 x institutional ULN (per Cockcroft-Gault formula) obtained =< 14 days prior to registration Calculated creatinine clearance >= 30 mL/min using the Calvert Formula Calculated/estimated or measured creatinine clearance at least 50 ml/min; note: creatinine clearance should be calculated using the Cockcroft-Gault formula; patients who will receive pemetrexed/cisplatin therapy must be obtained within 2 weeks of registration Creatinine < 1.5 x ULN. If >1.5 x ULN, patient may still be eligible if calculated creatinine clearance >50 mL/min (0.83mL/s) as calculated by the Cockcroft-Gault method. Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min within 30 days of day 1 of study Serum creatinine ? 2.0 mg/dL or creatinine clearance ? 40 mL/min measured or calculated by Cockroft Gault equation. Creatinine =< 1.5 mg/dl or creatinine clearance >= 60 cc/min (can be calculated by 24 hour urine or by the Cockroft-Gault formula) Creatinine =< 2.0 mg/dL OR creatinine clearance (calculated clearance permitted) >= 40 mL/min by Cockcroft-Gault formula Serum creatinine =< 1.5 mg/dL; if serum creatinine is > 1.5 mg/dL, calculate creatinine clearance using standard Cockcroft-Gault formula; creatinine clearance must be >= 50 mL/min to be eligible Serum creatinine =< 2.0 mg/dL or calculated creatinine clearance >= 50 mL/min as determined by the Cockcroft-Gault equation Obtained =< 21 days prior to registration: Creatinine =< 1.5 mg/dl OR creatinine > 1.5 mg/dl, estimated creatinine clearance must be >= 55 mL/minute by Cockcroft Gault formula Serum creatinine =< 1.5 mg/dL or creatinine clearance >= 50 mL/min (calculated by Cockcroft Gault equation) Creatinine ?1.2 mg/dL or clearance ?50ml/min (Cockcroft-Gault) Calculated creatinine clearance (by Cockroft-Gault) >= 50 mL/min or serum creatinine below 2 g/dL Creatinine ?1.5 mg/dL or calculated creatinine clearance using the Cockcroft-Gault formula ?60 mL/min or measured creatinine clearance Serum creatinine =< 1.5 mg/dL or calculated creatinine clearance >= 40 mL/min as determined by the Cockcroft-Gault equation Serum creatinine < 1.5 mg/dL or calculated creatinine clearance >= 50 mL/min within 30 days prior to registration estimated by the Cockcroft-Gault formula Serum creatinine calculated creatinine clearance by the method of Cockcroft and Gault (< 50mL/min) Patients must have a serum creatinine of less than or equal to 1.3 mg/dL or creatinine clearance > 70 ml/min as calculated by the Cockcroft-Gault formula Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min Serum creatinine =< 2 mg/dL, or calculated creatinine clearance > 50 mL/min (per the Cockcroft-Gault formula) Creatinine =< 1.5 mg/dl or creatinine clearance >= 60 mL/min/1.73 m^2 (calculated per Cockcroft & Gault formula) for subjects with creatinine levels above institutional normal Serum creatinine =< 2.0 mg/dL OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above 2 mg/dL (unless dysfunction is secondary to lymphoma involvement); creatinine clearance (Cr Cl) will be calculated with the use of the 24-hour creatinine clearance or modified Cockcroft-Gault equation Either serum creatinine > 1.7 mg/dL, or creatinine clearance < 50 mL/min calculated by the Cockcroft Gault method, eventually confirmed by measured creatinine clearance (or measured glomerular filtration rate [GFR] using plasma clearance methods) Serum creatinine =< 1.5 mg/dL, or calculated (using the formula of Cockcroft and Gault) or measured creatinine clearance >= 30 mL/min Serum creatinine =< 1.5 mg/dL and /or calculated creatinine clearance (using Cockcroft-Gault formula) >= 30 mL/min Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min Creatinine =< 1.5 mg/dL or creatinine clearance >= 40 mL/min using Cockcroft-Gault formula, within 14 days of study registration (within 30 days for pulmonary and cardiac assessments) Serum creatinine < 1.5 mg/dl within 7 days prior to starting the study drug or creatinine clearance rate (CCr) ? 50 mL/min within 7 days prior to starting the study drug determined by 24-hour collection or estimated by Cockcroft-Gault formula: CCr male = [(140 - age) x (wt in kg)]/[(Serum Cr mg/dl) x (72)] CCr female = 0.85 x (CrCl male) Creatinine =< 2.0 mg/dL OR calculated creatinine clearance >= 50 mL/min (as calculated by the Cockcroft-Gault method) Creatinine < 1.5 mg/dL OR creatinine clearance (by Cockcroft Gault formula) >= 50 mL/min Serum creatinine =< 1.5 x mg/dL and/or calculated creatinine clearance (using Cockcroft-Gault formula) >= 30 mL/min Serum creatinine less than or equal to 1.3 mg/dL; if creatinine is > 1 mg/dL the creatinine clearance should be > 40 mL/min as calculated using the Cockcroft-Gault formula Creatinine =< 1.5 mg/dL × ULN, or calculated creatinine clearance (determined as per Cockcroft-Gault) Creatinine < 1.5 mg/dl and/or creatinine clearance > 60 mL/min using the Cockcroft-Gault formula CERITINIB INCLUSION CRITERIA: Creatinine OR creatinine clearance < 1.5 mg/dL >= 30 mL/min (calculated by Cockgraft-Gault) for patients with creatinine levels above ULN Serum creatinine =< 1.5 mg/dL and/or calculated creatinine clearance >= 50 mL/min (via Cockroft and Gault) Adequate renal function, estimated or calculated creatinine clearance of > 50 mL/min (calculated using the formula of Cockcroft and Gault) -or- serum creatinine ? 2.0 mg/dL. Serum creatinine < 1.5 mg/dL and/or calculated creatinine clearance (using Cockcroft-Gault formula) >= 30 mL/min Serum creatinine =< 1.5 mg/dL (=< 133 umol/L) OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min Adequate renal function as defined by one of the following: \r\n• Serum Creatinine ?1.5 mg/dl OR \r\n• Serum Creatinine clearance > 50ml/min (calculated by Cockcroft-Gault formula) Creatinine =< 1.5 mg/dL or creatinine clearance by Cockcroft-Gault formula >= 60 mL/min Calculated creatinine clearance (by Cockroft-Gault) >= 50 ml/min or serum creatinine below 2 g/dL Serum creatinine =< 1.5 mg/dL, or if serum creatinine is > 1.5 mg/dL, creatinine clearance must be >= 50 mL/min (calculate creatinine clearance using the Cockcroft-Gault formula Creatinine =< 1.5 mg/dl OR creatinine clearance >= 55 mL/min using the Cockcroft-Gault equation for patients with creatinine levels above 1.5 mg/dl Serum creatinine < 1.5 mg/dL and/or calculated creatinine clearance (using Cockcroft-Gault formula) >= 30 mL/min Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 60 mL/min OR 24-hour urine creatinine clearance >= 60 mL/min Serum creatinine level to be < 2 mg/dl or estimated creatinine clearance (CrCl) must be equal or greater than 40 mL/min/1.73 m^2 as calculated by the Cockcroft-Gault formula Creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min Serum creatinine of =< 1.5 mg/dL; if creatinine > 1.5 mg/dL creatinine clearance must be > 60 mL/min within 7 days prior to treatment either measured or calculated using a standard Cockcroft and Gault formula Serum creatinine =< 1.6 mg/dL and creatinine clearance >= 30 ml/min; creatinine clearance will be calculated using the Cockcroft-Gault equation Serum creatinine > 2.0 mg/dL or 177 ?mol/L or creatinine clearance < 40 mL/min (using the Cockcroft-Gault formula) Creatinine =< 1.6 mg/dL; if over 1.6 then the calculated creatinine clearance must be >= 55 ml/min using the Cockcroft-Gault formula, obtained =< 7 days prior to registration Serum creatinine =< 2 mg/dL. The Cockcroft-Gault formula will be used to calculate creatinine clearance in all subjects. Serum creatinine =< 1.5 mg/dL or creatinine clearance >= 50 mL/min (calculated by Cockcroft Gault equation) =< 14 days prior to registration Serum creatinine =< 2.0 mg/dL or creatinine clearance >= 40 mL/min (measured or calculated according to the method of Cockcroft and Gault), within 28 days of day 0. Obtained =< 21 days prior to registration: Creatinine =< 1.0 mg/dL or creatinine clearance >= 45 ml/min using the Cockcroft-Gault formula Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min Serum creatinine levels =< 1.5 mg/dl and calculated (by Cockcroft-Gault formula) or measured creatinine clearance >= 50 mL/min, obtained within 14 days prior to registration for protocol therapy Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min Creatinine =< 2.0 mg/dL, OR calculated creatinine clearance >= 30 mL/min (calculated by the Cockcroft and Gault method) Serum creatinine =< 1.5 mg/dL or creatinine clearance >= 50 mL/min (calculated by Cockcroft Gault equation) Serum creatinine =< 1.5 mg/dL (=< 120 umol/L) OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockroft-Gault formula) >= 30 mL/min OR 24-hour urine creatinine clearance >= 30 mL/min Blood creatinine =< 1.5 mg/dL (if blood creatinine is > 1.5 mg/dL, calculate creatinine clearance using standard Cockcroft and Gault method or using a 24 hour urine collection for creatinine; creatinine clearance must be > 50 mL/min), within 2 weeks of the first dose of study treatment Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min Renal insufficiency at the time of screening, defined as serum creatinine > 2.0 mg/dL or creatinine clearance < 50 mL/min (either actual or calculated value may be used), within 7 days of initiation of protocol therapy; creatinine clearance will be the primary eligibility criteria in determining renal insufficiency; the Cockcroft-Gault formula should be used for calculating creatinine clearance values Serum creatinine > 2.0 mg/dL or creatinine clearance < 40 mL/min measured or calculated by Cockroft-Gault equation. Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min Creatinine less than or equal to 1.5 mg/dL or creatinine clearance greater than 40 mL/min/1.73 m2 for patients with creatinine levels above institutional normal, as calculated by the Cockcroft Gault formula. Serum creatinine =< 2.0 g/dL or calculated creatinine clearance >= 60 mL/min (Cockcroft-Gault method) Adequate renal function, with creatinine =< 1.3 mg/dl or calculated creatinine clearance >= 60 ml/min by Cockcroft and Gault equation using parameters of age, weight (kg), and baseline serum creatinine (mg/dl) Any of the following laboratory abnormalities: Absolute neutrophil count(ANC) < 1,000/µL, Platelet count < 75,000/µL or < 50,000/µL for patients in whom ? 50% of bone marrow nucleated cells are plasma cells, Hemoglobin < 8 g/dL, Creatinine clearance < 45 mL/min according to Cockcroft-Gault formula. If creatinine clearance calculated from the 24 hour urine sample is ? 45 mL/min, patient will qualify for the trial, Aspartate transaminase (AST) or Alanine transaminase (ALT) > 3.0 × Upper Limited Normal (ULN), Serum total bilirubin > 2.0 mg/dL or > 3.0 × ULN for patients with hereditary benign hyperbilirubinaemia. Creatinine: =< 1.5 mg/dL, OR calculated creatinine clearance >= 40 mL/min (calculated by the modified Cockcroft and Gault method) Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault method) >= 50 mL/minute within 14 days prior to treatment Serum creatinine < 2.0 mg/dL or calculated creatinine clearance (CrCl) > 45 mL/min (Cockcroft-Gault) Renal insufficiency (serum creatinine levels > 2.5 mg/dL, calculated creatinine clearance [Crcl] with Cockcroft-Gault formula, < 45 ml/min) Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min Serum creatinine =< 1.3 mg/dL; patients with serum creatinine > 1.3 mg/dL may be eligible if creatinine clearance (CrCl) >= 55 mL/min based on the standard Cockcroft and Gault formula Creatinine =< 2.5 mg/dL OR calculated creatinine clearance >= 50 mL/min (as calculated by the Cockcroft-Gault method) Serum creatinine < 1.5 mg/dL or calculated creatinine clearance >= 50 mL/min within 30 days prior to registration estimated by the Cockcroft-Gault formula Creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min Serum creatinine =< 3.0 mg/dL or a calculated creatinine clearance of at least 15 mL/min (using the Cockcroft and Gault method) Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min Serum creatinine =< 1.5 mg/dL or creatinine clearance > 45 mL/min; use either measured or calculated with Cockcroft-Gault formula Creatinine =< 1.5 mg/dL or calculated creatinine clearance >= 40 mL/min per the Cockcroft and Gault formula Creatinine < 2.0 mg/dl; renal function assessed by calculated creatinine clearance as follows: phase I subjects must have calculated creatinine clearance >= 60 ml/min by Cockcroft-Gault formula Serum creatinine =< 2.5 mg/dL or a calculated creatinine clearance of at least 50 mL/min (using the Cockcroft and Gault method) Adequate renal function as evidenced by serum creatinine less than 1.5 mg/dL or calculated creatinine clearance greater than 40 mL/min per the Cockcroft and Gault formula. =< 10 days prior to enrollment/randomization: Creatinine =< 1.5 mg/dL or creatinine clearance >= 50 mL/min calculated by the Cockcroft-Gault method Serum creatinine ? 1.5 mg/dL or a calculated creatinine clearance of ? 60 mL/min as determined by the Cockcroft-Gault equation Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 60 mL/min Serum creatinine ? 1.5 mg/dL or calculated creatinine clearance (CrCl) of ? 60 mL/hour by the Cockroft-Gault equation; Serum creatinine ? 1.5 mg/dL or creatinine clearance > 45 mL/min according to Cockcroft?Gault formula; (If creatinine clearance calculated from a 24-hour urine sample is ?45 mL/min, the subject will qualify for the study). Creatinine =< 1.5 mg/dL to receive weekly intravenous cisplatin*; *patients whose serum creatinine is between 1.5 and 1.9 mg/dL are eligible for cisplatin if the estimated creatinine clearance is >= 30 ml/min; for the purpose of estimating the creatinine clearance, the formula of Cockcroft and Gault for females should be used Serum creatinine < 1.5 mg/dL or calculated creatinine clearance >= 50 ml/min (by Cockcroft-Gault formula) within 14 days prior to registration Adequate renal function as evidenced by serum creatinine less than or equal to (<=) 1.5 milligram per deciliter (mg/dL) or calculated creatinine clearance >=50 millimeter per minute (mL/min) according to the Cockcroft and Gault formula. Creatinine ? 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) ? 50 mL/min OR 24-hour urine creatinine clearance ? 50 mL/min Calculated creatinine clearance greater than 45 mg/dl using the Cockcroft-Gault formula Creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min Serum creatinine =< 2 mg/dL or a calculated creatinine clearance of >= 50 mL/min (using the Cockcroft and Gault method) Clinical laboratory values should be as follows: WBC < 30,000/mL Blasts in PB ? 20,000. Treatment with Hydroxyurea is permitted up to 24 hrs prior to BL-8040 administration to achieve blast counts < 20,000 prior to enrollment. Creatinine < 1.3 mg/dL; if Creatinine is > 1 mg/dL the Creatinine clearance should be > 40 mL/min as calculated using the Cockcroft-Gault formula. Creatinine =< 1.5 mg/dL or creatinine clearance >= 50 mL/min calculated by the Cockcroft-Gault method Serum creatinine clearance >=50 ml/min (calculated with Cockroft-Gault formula); creatinine for children =<1.5 mg/dl or =< 2 times upper limit of normal for age (whichever is less) Creatinine =< 1.5 mg/dL or creatinine clearance >= 40mL/mon (using Cockcroft-Gault formula) Creatinine =< 1.5 mg/dL, or calculated creatinine clearance (determined as per Cockcroft-Gault) >= 50 mL/min Creatinine =< 1.6 mg/dl (for patients with > 1.6 mg/dl, calculated or measured creatinine clearance must be >= 60 mL/minute [Cockcroft-Gault]) Serum creatinine ? 2.0 mg/dL or creatinine clearance ? 40 mL/min measured or calculated by Cockcroft-Gault equation. Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min Creatinine =< 1.5 mg/dl OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 ml/min OR 24-hour urine creatinine clearance >= 50 ml/min Serum creatinine ?1.5 mg/dL, and creatinine clearance ? 50 ml/min as measured by Cockcroft and Gault formula Serum creatinine ? 1.7 mg/dL or calculated creatinine clearance ? 50 mL/min per the Cockcroft and Gault formula Creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault Calculated (calc.) creatinine clearance >= 50 mL/min by Cockcroft-Gault Creatinine clearance >= 51 mL/min/1.73 m^2 by Cockcroft-Gault Calculated creatinine clearance >= 40 mL/min (Cockcroft-Gault formula) Calculated creatinine clearance >= 50 mL/min (per the Cockcroft-Gault formula) Adequate renal function within 4 weeks prior to study entry, defined as serum creatinine less than or equal to 1.5 x ULN for the lab or measured or calculated creatinine clearance greater than 40 mL/min by Cockcroft-Gault formula. Adequate renal function as demonstrated by serum creatinine ?1.5 x ULN or creatinine clearance>60 mL/min as calculated by the Cockroft and Gault formula Creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault Creatinine clearance >= 60 mL/min by the modified Cockcroft-Gault formula; timeline: within 3 weeks prior to enrollment Adequate renal function defined as serum creatinine less than 1.5 X ULN (upper limit of normal) or use SI units or calculated creatinine clearance greater than or equal to 50 mL/min per the Cockcroft and Gault formula Creatinine clearance > 50 ml/min calculated by the Cockcroft-Gault formula Renal function assessed by calculated creatinine clearance >= 60 ml/min by Cockcroft-Gault formula Creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault Acceptable renal function, as specified below:: • Creatinine clearance (CrCl) calculated by Cockroft-Gault formula of ? 60 mL/min. Calculated creatinine clearance ? 30 mL/min (Cockcroft-Gault formula) Adequate renal function defined as calculated creatinine clearance ?30 milliliters per minute (mL/min) per the Cockcroft and Gault formula ENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: Calculated creatinine clearance (determined as per Cockcroft-Gault) >= 50 mL/min Creatinine clearance of >= 60 mL/min per the Cockcroft-Gault formula Creatinine clearance of >= 30 ml/min; creatinine clearance should be determined by the Cockcroft-Gault formula within 14 days of enrollment to trial Calculated creatinine clearance > 50 mL/min (per the Cockcroft-Gault formula) Creatinine clearance (by Cockcroft Gault formula) <40 mL/min Creatinine clearance > 30 mL/min by Cockcroft-Gault formula PHASE I: Calculated creatinine clearance (CrCl) >= 60 mL/min calculated by Cockcroft-Gault formula PHASE IB: Calculated creatinine clearance (CrCl) >= 60 mL/min calculated by Cockcroft-Gault formula Renal function: >= 60 ml/min (actual or calculated by the Cockcroft-Gault method) or a creatinine =< the upper limits of normal Calculated creatinine clearance >= 40 mL/min (Cockcroft-Gault formula) Creatinine clearance ? 30 ml/min by Cockcroft-Gault formula Obtained within 28 days prior to registration: Calculated creatinine clearance >= 30 but =< 60 mL/min (Cockcroft-Gault) Within 7 days of enrollment and with 24 h of starting lymphodepleting chemotherapy: Calculated creatinine clearance (Cockcroft-Gault) >= 50.0 mL/min. Within 28 days prior to registration: Calculated creatinine clearance >= 40 mL/min\r\n* Cockcroft-Gault formula will be used to calculate creatinine clearance Creatinine clearance >= 50 mL/min for Cohort #1 (DLBCL) and >= 30 mL/min for Cohort #2 (MCL) per the Cockcroft-Gault formula, performed within 14 days prior to day 1 of protocol therapy Creatinine clearance (by Cockcroft Gault formula) greater than or equal to 50 mL/min Adequate renal function as defined by calculated creatinine clearance =< 60 mL/min (Cockcroft-Gault formula) Creatinine clearance > 50mls/min (calculated with Cockroft-Gault formula); (** = calculated by Cockcroft and Gault's formula) Creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault Participant must have adequate renal function as demonstrated by a creatinine >= 30 mL/min; calculated by the Cockroft Gault formula or measured by 24 hours urine collection. Calculated creatinine clearance > 40 cc/min by the modified Cockcroft-Gault formula for adults or the Schwartz formula for pediatrics Subjects must have adequate renal function with a creatinine clearance of >= 40 mL/min as determined by the Cockcroft-Gault calculation Renal function: creatinine clearance by Cockcroft-Gault formula >= 30 mL/min must be met during screening (within 21 days) and also prior to study drug administration on cycle 1 day 1 Creatinine clearance > 30 mL/min by Cockcroft-Gault formula Creatinine clearance >= 40 mL/min/1.73 m^2 by the Cockcroft-Gault formula Creatinine clearance > 30 ml/min according to Cockcroft-Gault Within 14 days of the first study treatment: Creatinine clearance >= 30 mL/min by Cockcroft-Gault formula (or local institutional standard method) Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula creatinine clearance ? 60 mL/min (Cockroft & Gault formula); Creatinine clearance >= 30 mL/min according to the Cockcroft-Gault formula Participant must have adequate renal function as demonstrated by a creatinine clearance ? 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24-hours urine collection. Creatinine clearance (Cockcroft Gault) ? 60 mL/min Within 14 days prior to planned start of treatment: Creatinine clearance of >= 60 mL/min per the Cockcroft-Gault formula Adequate renal function as demonstrated by serum creatinine ?1.5 x ULN or creatinine clearance calculation ?60 mL/min as calculated by the Cockcroft and Gault formula Creatinine clearance greater than or equal to 50 mL/min (Cockcroft-Gault) Serum creatinine clearance >= 50 ml/min (calculated with Cockcroft-Gault formula) Renal function: >= 60 ml/min (actual or calculated by the Cockcroft-Gault method) or a creatinine =< the upper limits of normal at cycle 1 day 1 of TPF The patient has serum creatinine clearance ?50 mL/min by the Cockcroft-Gault formula. Creatinine clearance (by Cockcroft Gault formula or measured) >= 50 mL/min Creatinine clearance (based on modified Cockcroft-Gault formula) ? 45 ml/min. Renal function assessed by calculated creatinine clearance: \r\n* Calculated creatinine clearance >=30 ml/min by Cockcroft-Gault formula Calculated creatinine clearance >= 30 mL/min; Cockcroft-Gault formula will be used to calculate\r\ncreatinine clearance PHASE I: Subjects must have calculated creatinine clearance >= 60 ml/min by Cockcroft-Gault formula, obtained =< 7 days prior to registration PHASE II: Subjects must have calculated creatinine clearance >= 30 ml/min by Cockcroft-Gault formula, obtained =< 7 days prior to registration Adequate renal function: calculated creatinine clearance > 30 ml/min (Cockcroft-Gault) Serum creatinine clearance >= 50 ml/min (calculated by Cockroft-Gault formula) Creatinine clearance >= 30 mL/min by Cockcroft-Gault formula Calculated creatinine clearance >= 50 mL/min (calculated by the Cockcroft-Gault formula), obtained within 30 days of study registration, or Creatinine clearance (calculated by the Cockroft-Gault formula) >= 30 ml/min Creatinine clearance < 60 mL/min (calculated by Cockcroft-Gault formula) Serum creatinine clearance equal or more than 50 ml/min (calculated with Cockcroft-Gault formula) Calculated creatinine clearance by Cockcroft-Gault formula >= 30 ml/min obtained within 2 weeks prior to registration RANDOMIZED PHASE II (ARMS K AND L): Calculated creatinine clearance by Cockroft-Gault formula >= 30 ml/min, obtained within 2 weeks prior to registration Calculated creatinine clearance according to the formula of Cockroft and Gault >= 50 mL/min Subjects must have adequate renal function with a creatinine clearance of >= 40 mL/min as determined by the Cockcroft-Gault calculation Patients enrolled in the dose escalation phase who are not enrolled on the expansion cohorts must have calculated creatinine clearance >= 50 ml/min by Cockcroft-Gault formula; patients enrolled in the dose expansion phase must have calculated creatinine clearance >= 40 ml/min by Cockcroft-Gault formula, without use of growth factor support for 1 week Serum creatinine < 2x normal, or creatinine clearance (as determined by the Schwartz formula Cockcroft and Gault) > 40ml/min/m^2 or 70ml/min Renal function: >= 60 ml/min (actual or calculated by the Cockcroft-Gault method) Creatinine Clearance >= 60 mg/mL as calculated by the modified Cockraft-Gault formula Creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault Creatinine clearance >= 50 ml/min measured by Cockcroft-Gault Creatinine (Cr) clearance > 50 mL/min by Cockcroft-Gault calculation Creatinine clearance >= 30 by Cockcroft-Gault formula Creatinine clearance >= 30 mL/min according to Cockcroft-Gault formula Creatinine clearance >= 50 mls/min by Cockcroft-Gault Adequate renal function as evidenced by calculated creatinine clearance ? 30 millimeter/ minute (mL/min) according to the Cockcroft and Gault formula. Creatinine clearance >= 60 mL/min/1.73 m^2 as calculated by Cockcroft-Gault Calculated creatinine clearance >= 40 mL/min (Cockcroft-Gault formula) Creatinine clearance >= 30 mL/minute (calculated by Cockcroft-Gault formula) Creatinine clearance < 30 mL/minute (calculated by Cockcroft-Gault formula) Renal function assessed by calculated creatinine clearance (CrCl) must be >= 60 ml/min by Cockcroft-Gault formula Subjects must have calculated creatinine clearance >= 30ml/min by Cockcroft-Gault formula Creatinine clearance > 30 ml/min calculated by modified Cockcroft-Gault formula Adequate renal function defined as calculated creatinine clearance greater than or equal to 30 mL/min per the Cockcroft and Gault formula. Creatinine clearance >= 40 mL/min\r\n* To be calculated by modified Cockcroft-Gault formula Adequate renal function defined as creatinine clearance greater than 40 mL/min calculated per the Cockcroft and Gault formula Calculated creatinine clearance by Cockroft-Gault formula >= 30 mL/min obtained within 4 weeks prior to registration Calculated creatinine clearance by Cockroft-Gault formula >= 30 ml/min (** = calculated by Cockcroft and Gault's formula) Creatinine clearance >= 30 mL/min as calculated by Cockcroft-Gault formula within 4 weeks of pre-registration Creatinine clearance > 30 ml/min calculated by modified Cockcroft-Gault formula Calculated creatinine clearance (by Cockroft-Gault) of > 50 ml/min Creatinine clearance > 30 mL/min (calculated according to Cockcroft - Gault formula) unless due to lymphoma with documentation of normal function prior to onset of lymphoma Adequate renal function: calculated creatinine clearance > 30 ml/min (Cockcroft-Gault) Renal insufficiency, defined as creatinine clearance < 30 mL/min (either actual or calculated value), within 21 days of initiation of protocol therapy; the Cockcroft-Gault formula should be used for calculating creatinine clearance values Phase Ib subjects must have calculated creatinine clearance >= 50 ml/min by Cockcroft-Gault formula, phase IIa subjects must have calculated creatinine clearance >= 40 ml4/min by Cockcroft-Gault formula Creatinine clearance greater than or equal to 30 mL/min to less than 45 ml/min (calculated by Cockcroft-Gault formula) Calculated creatinine clearance >= 30 mL/min by Cockcroft-Gault within 14 days before enrollment Serum creatinine clearance >= 50 ml/min by the Cockcroft-Gault formula Calculated creatinine clearance of >= 40 ml/min; as per Cockcroft-Gault formula Acceptable renal function defined as serum creatinine ? 1.5 times ULN or calculated creatinine clearance ? 60mL/min (by Cockcroft Gault formula) Creatine clearance < 45mL/min according to Cockcroft-Gault formula. If creatine clearance calculated from the 24-hour urine sample is ? 45 mL/min, patient will qualify for the study Creatinine clearance < 45 mL/min (either actual or calculated value), at time of screening evaluation; the Cockcroft-Gault formula should be used for calculating creatinine clearance values Adequate renal function as evidenced by calculated creatinine clearance > 30 ml/min according to the Cockcroft and Gault formula or by 24 hour urine creatinine clearance Calculated creatinine clearance must be > 60 mL/min (by Cockcroft-Gault) Adequate renal function, defined as calculated creatinine clearance greater than 40 mL/min per the Cockcroft and Gault formula. Renal function assessed by calculated creatinine clearance as follows:\r\n* Phase Ib subjects must have calculated creatinine clearance >= 50 mL/min by Cockcroft-Gault formula\r\n* Phase IIa subjects must have calculated creatinine clearance >= 30 mL/min by Cockcroft-Gault formula Renal function: >= 60 ml/min (actual or calculated by the Cockcroft-Gault method) or a creatinine =< the upper limits of normal Have a creatinine clearance of >= 90 ml/min, as calculated by the Cockroft-Gault formula Calculated creatinine clearance must be > 40 mL/min (by Cockcroft-Gault) Creatinine clearance > 50 mL/min via Cockcroft and Gault Patients must have calculated creatinine clearance >= 60 ml/min by Cockcroft-Gault formula or 24 hour urine demonstrating creatinine clearance (CrCl) >= 60 ml/min Renal function assessed by calculated creatinine clearance >= 30ml/min by Cockcroft-Gault formula Calculated creatinine clearance ? 30 ml/min by Cockcroft-Gault formula • Total bilirubin < = 2 x ULN Adequate renal function Serum Creatinine <=ULN or Creatinine Clearance calculated by Cockcroft and Gault's formula > 60 mL/min Calculated creatinine clearance (Cockroft-Gault) >= 30ml/min Creatinine clearance >= 20 mL/min/1.73 m^2 by Cockcroft-Gault Calculated creatinine clearance >= 60 ml/min (by Cockroft-Gault formula) within 30 days prior to registration Adequate hepatic and renal function laboratory values within 14 days prior to registration: Calculated (Cockcroft and Gault formula) or measured creatinine clearance >= 30 mL/min Calculated creatinine clearance >= 50ml/min; for adults this will be calculated per the Cockgroft-Gault formula and in pediatric cases this will be calculated per the Schwartz formula Calculated creatinine clearance >= 60 mL/min calculated by the Cockcroft-Gault formula Adequate renal function Serum Creatinine <=ULN or Creatinine Clearance calculated by Cockcroft and Gault's formula > 60 mL/min. Calculated (method of Cockroft-Gault) creatinine clearance <60 mL/min. Subjects with creatinine clearance <40 mL/minute at Screening, as calculated by the Cockcroft-Gault formula. Calculated creatinine clearance must be >= 30 mL/minute based on Cockcroft-Gault formula Creatinine clearance >= 30 ml/min or calculated creatinine clearance >= 30 ml/min according to the Cockcroft-Gault formula A calculated creatinine clearance (Cockcroft Gault) of >= 30 ml/min Calculated creatinine clearance (Cockcroft-Gault formula) of >= 45 mL/min Calculated creatinine clearance >= 40 mL/min/1.73 m^2 based on Cockcroft and Gault method Calculated creatinine clearance (Cockcroft-Gault formula) > 50 ml/min OR 24-hour urine creatinine clearance > 50 ml/min Renal function assessed by calculated creatinine clearance as follows:\r\n* Subjects must have calculated creatinine clearance >= 30 ml/min by Cockcroft-Gault formula (Phase I)\r\n* Subjects must have calculated creatinine clearance >= 30 ml/min by Cockcroft-Gault formula (Phase II) Calculated creatinine clearance >= 30 ml/min by Cockcroft-Gault formula Cohort A: Calculated creatinine clearance >= 40 mL/min for patients receiving pemetrexed (by Cockcroft-Gault) Cohort A: Calculated creatinine clearance >= 30 mL/min for patients receiving gemcitabine or paclitaxel (by Cockcroft-Gault) Calculated creatinine clearance >= 60ml/min by Cockcroft-Gault formula Adequate renal function defined as calculated creatinine clearance greater than 50 mL/min per the Cockroft and Gault formula. Patient has adequate renal function (calculated creatinine clearance of ?30 mL/min according to the Cockroft-Gault) Creatinine clearance ? 50 mL/min measured by Cockcroft-Gault method. Creatinine clearance >= 50 mL/min/1.73 m^2 (Cockcroft-Gault formula) Creatinine clearance < 30 mL/min by Cockcroft-Gault estimate Calculated creatinine clearance >= 30 ml/min by Cockcroft-Gault formula Calculated creatinine clearance > 40 cc/min by the modified Cockcroft-Gault formula Calculated creatinine clearance >= 30 mL/min (based on the Cockcroft and Gault method) Patients with calculated creatinine clearance (Cockroft-Gault) less than 35 mL/min Adequate renal function as defined by calculated creatinine clearance =< 40 mL/min (Cockcroft-Gault formula) Creatinine clearance =< 30 mL/minute (calculated by Cockcroft-Gault formula) Calculated creatinine clearance >= 60 mL/min (Cockcroft-Gault formula) Participants must have adequate renal function with a calculated creatinine clearance of > 60 ml/min from a serum specimen collection at baseline using the Cockcroft-Gault formula Adequate renal function defined as serum creatinine <1.5×ULN (or calculated creatinine clearance ?50 mL/min per the Cockcroft and Gault formula). Adequate renal function as demonstrated by serum creatinine ?1.5 x ULN or creatinine clearance calculation ?60 mL/min as calculated by the Cockcroft and Gault formula Adequate renal function defined as calculated creatinine clearance ?30 mL/min per the Cockcroft and Gault formula. Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance >= 50 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation Creatinine clearance ? 50 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate calculation Creatinine clearance >= 50 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation. STUDY TREATMENT: Creatinine clearance >= 50 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation within 14 days prior to the first study treatment. Serum creatinine =< 1.5 x ULN or creatinine clearance >= 50 mL/min on the basis of the Cockcroft?Gault glomerular filtration rate estimation Serum creatinine =< 1.5 x ULN or creatinine clearance >= 50 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation. Serum creatinine =< 1.5 x ULN OR creatinine clearance >= 50 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation, obtained within 7 days prior to first study treatment Serum creatinine =< 1.5 x ULN or creatinine clearance >= 50 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation Obtained within 14 days prior to the first study treatment (cycle 1, day 1): serum creatinine =< 1.5 x ULN or creatinine clearance =< 50 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation Within 14 days prior to registration: Serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 40 mL/min on the basis of measured CrCl from a 24-hour urine collection or Cockcroft-Gault glomerular filtration rate estimation Within 14 days prior to the first study treatment (cycle 1, day 1): Serum creatinine =< 1.25 x ULN or creatinine clearance >= 60 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation Serum creatinine =< 1.5 x ULN or creatinine clearance >= 50 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation Serum creatinine ? 1.5 x ULN or creatinine clearance ? 50 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation within 14 days prior to the first study treatment (cycle 1, day 1) Serum creatinine =< 1.5 x ULN or creatinine clearance >= 50 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation Within 14 days prior to the first study treatment (cycle 1, day 1): Serum creatinine =< 1.5 x ULN or creatinine clearance >= 50 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation. Creatinine ? 2 x ULN OR creatinine clearance > 30 mL/min based on the Cockroft-Gault glomerular filtration rate (GFR) estimation within 14 days prior to registration Serum creatinine =< 1.5 x ULN or creatinine clearance >= 50 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation Serum creatinine ? 1.5 x ULN or creatinine clearance ? 50 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation: Creatinine clearance > 50 mL/min (assessed by Cockcroft Gault estimation) Within 14 days prior to the first study treatment (cycle 1, day 1): Serum creatinine =< 1.5 x ULN or creatinine clearance >= 50 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation Creatinine clearance > 50 mL/min (assessed by Cockcroft Gault estimation) Obtained within 14 days prior to the first study treatment (cycle 1, day 1); serum creatinine ? 1.5 x ULN or creatinine clearance ? 50 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation Serum creatinine =< 1.5 x ULN or creatinine clearance >= 50 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation (obtained within 14 days prior to the first study treatment [course 1, day 1]) Alkaline phosphatase 2.5 ULN with the following exception: Patients with liver or bone inv ULN or creatinine clearance 50 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation: (140 age) (weight in kg) (0.85 if female) 72 (serum creatinine in mg/dL) Serum creatinine =< 1.5 x ULN OR creatinine clearance >= 50 mL/min/1.73 m^2 by Cockcroft-Gault estimation Within 14 days prior to first study treatment: Serum creatinine =< 1.5 x ULN OR creatinine clearance >= 50 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation Measured or calculated creatinine clearance >=50 milliliters per minute (mL/min) on the basis of the Cockcroft-Gault glomerular filtration rate estimation Cancer-Specific Inclusion Criteria: Creatinine clearance > 50 mL/min (assessed by Cockcroft Gault estimation) and creatinine < 1.5 x ULN Creatinine clearance >= 50 mL/min (assessed by Cockcroft Gault estimation) Estimated creatinine clearance >= 70 cc/min (calculated by Cockcroft-Gault formula) Estimated creatinine clearance >= 50 ml/min (Cockcroft-Gault based on actual weight) Estimated creatinine clearance >= 30 ml/min (Cockcroft-Gault) Estimated creatinine clearance > 30 cc/min within four weeks of enrollment Creatinine clearance (as estimated by Cockcroft Gault) ? 60 cc/min Creatinine clearance (as estimated by Cockcroft Gault) >= 60 cc/min Estimated creatinine clearance greater than or equal to 30 ml/min (Cockcroft-Gault) or serum creatinine less than or equal to 2 x ULN Estimated creatinine clearance >= 30 ml/min (Cockcroft-Gault) Estimated creatinine clearance >= 30 ml/min (Cockcroft-Gault) Serum creatinine clearance of < 30 mL/min as estimated by the Cockcroft-Gault method Creatinine clearance (as estimated by Cockcroft Gault) >= 60 cc/min Creatinine clearance (as estimated by Cockcroft Gault) >= 50 cc/min. Estimated creatinine clearance greater than or equal to 60 ml/min (Cockcroft-Gault) Estimated creatinine clearance by Cockcroft-Gault >=40 milliliter per minute (mL/min) / 1.73 square meter (m^2); Estimated creatinine clearance >= 30 ml/min (Cockcroft-Gault) Creatinine =< 1.5 x upper limit of normal (ULN), or creatinine clearance >= 50 mL/min (estimated by Cockcroft-Gault or measured) Creatinine clearance (estimated) >= 50 cc/min by Cockcroft Gault or 24 hour urine Estimated creatinine clearance (Cockcroft-Gault) >40 mL/min Measured or estimated creatinine clearance of >= 30 mL/min, (Cockcroft and Gault) AT THE TIME OF INFUSION: Creatinine clearance (as estimated by Cockcroft Gault or Schwartz) ? 60 ml/min Estimated creatinine clearance (Cockcroft-Gault) > 60 mL/min Estimated creatinine clearance >= 30 mL/min (using Cockcroft-Gault) Estimated creatinine clearance (CCL) > 60 cc/min Serum creatinine ?2 mg/dL or Estimated Creatinine Clearance ?30 mL/min (Cockcroft-Gault). Creatinine clearance (as estimated by Cockcroft Gault) > 60 mL/min Estimated Creatinine Clearance 50 ml/min (Cockcroft-Gault) or serum creatinine 1.5 x ULN Estimated creatinine clearance >= 30 ml/min (Cockcroft-Gault) Estimated creatinine clearance >= 50 cc/min Creatinine clearance (as estimated by Cockcroft Gault) ? 60 cc/min Within 28 days prior to registration: Creatinine clearance (CrCl) >= 50 mL/min., as estimated by the Cockcroft and Gault formula; estimated creatinine clearance is based on actual body weight Renal function: Estimated creatinine clearance by Cockcroft-Gault formula ? 45 mL/min. Participants must have creatinine clearance greater than or equal to 50 mL/min as measured by 24-hour urine or estimated by the Cockcroft-Gault formula. Estimated creatinine clearance greater than 40 mL/minute (using the Cockcroft-Gault formula and actual body weight) Estimated creatinine clearance (CrCl) >= 50 mL/min/1.73 m^2 according to the Cockcroft-Gault formula, within 14 days prior to registration Renal: For patients > 13.0 years of age at the time of enrollment: estimated creatinine clearance > 50 mL/minute (using the Cockcroft-Gault formula and actual body weight). For patients < 13.0 years of age at enrollment: Glomerular Filtration Rate (GFR) estimated by the updated Schwartz formula ? 90 mL/min/1.73 m2. If the estimated GFR is < 90 mL/min/1.73 m^2, then renal function must be measured by 24-hour creatinine clearance or nuclear GFR, and must be > 50 mL/min/1.73 m^2. Estimated creatinine clearance >= 30 mL/min according to the Cockcroft-Gault formula Renal function: Estimated creatinine clearance by Cockcroft-Gault formula ? 45 mL/min and serum creatinine ? 2 mg/dL Estimated creatinine clearance (eClCR) >45 mL/min (with eCLCR to be calculated by the Cockcroft-Gault formula, or Adequate renal function defined by an estimated creatinine clearance >= 40 mL/min according to the Cockcroft-Gault formula (or local institutional standard method). Estimated creatinine clearance ? 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method) Estimated creatinine clearance >= 30 mL/min according to the Cockcroft-Gault formula have adequate renal function, defined as having a serum creatinine ?1.5 × ULN and a creatinine clearance ?40mL/min (estimated using the Cockcroft-Gault formula); Estimated creatinine clearance ? 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method) Estimated creatinine clearance >= 30 ml/min (calculated according using Cockcroft–Gault formula) STUDY TREATMENT: Creatinine clearance of 20 ml/min or greater as measured by the Cockroft-Gault formula Estimated creatinine clearance of < 30 mL/min, calculated using the formula of Cockcroft and Gault at the time of screening Patients must have an estimated creatinine clearance greater than 50/ml per minute by the following formula (Cockcroft-Gault); serum creatinine value must be within 28 days prior to registration Creatinine clearance >= 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method) Estimated creatinine clearance >= 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method) Estimated creatinine clearance >= 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method) For patients >= 13.0 years of age at the time of enrollment: estimated creatinine clearance > 50 mL/minute (using the Cockcroft-Gault formula and actual body weight) Serum creatinine =< 1.5 x upper limit of normal (ULN) or estimated creatinine clearance >= 60 ml/min per modified Cockcroft-Gault formula Estimated serum creatinine clearance >= 50 ml/min (using the Cockcroft-Gault formula) and/or serum creatinine =< 1.6 mg/dL; renal function will be calculated using ideal body weight (IBW), unless a patient weighs > 40% of their IBW, then adjusted body weight will be utilized Estimated creatinine clearance ? 30mL/min (Cockcroft-Gault formula) Within 21 days prior to C1D1: Estimated creatinine clearance of >= 30 mL/min, calculated using the formula of Cockcroft and Gault Creatinine clearance of >= 50 mL/min (estimated by the Cockcroft-Gault [C-G] formula) The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m^2 as calculated by the Cockcroft-Gault Formula Estimated serum creatinine clearance >= 60 ml/min (using the Cockroft-Gault formula and/or serum creatinine =< 1.6 mg/dL Estimated serum creatinine clearance >= 50 ml/min (using the Cockcroft-Gault formula) Creatinine < 1.5 x ULN or creatinine clearance > 60 ml/min according to Cockroft-Gault formula Estimated creatinine clearance > 30 mL/min according to the Cockcroft-Gault formula Estimated creatinine clearance of >= 30 mL/min, calculated using the formula of Cockcroft and Gault Severely impaired renal function, defined as creatinine clearance (CrCl) ? 30 mL/min estimated by the Cockcroft-Gault formula Estimated creatinine clearance > 40 mL/min by the Cockcroft-Gault formula Estimated (Cockcroft-Gault formula) or measured creatinine clearance <40 mL/min. Estimated creatinine clearance of >= 30 mL/min, calculated using the formula of Cockcroft and Gault Estimated creatinine clearance of < 30 mL/min, calculated using the formula of Cockcroft and Gault (140-Age) • Mass (kg)/(72 • creatinine mg/dL); multiply by 0.85 if female. Creatinine =< 2.0 x IULN OR estimated creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault formula Estimated creatinine clearance of >= 50 mL/min, calculated using the formula of Cockroft and Gault Subject's estimated creatinine clearance (Cer) is less than 30 milliliter (mL)/minute (min) by the Cockcroft and Gault formula (Creatinine Clearance (mL/min) = (140 - age)(weight (wt) kilogram (kg) / 72 x serum creatinine (milligram (mg)/100 mL) [Cockcroft, 1976] at Screening. Adequate renal function as defined by an estimated creatinine clearance > 30 mL/min according to the Cockcroft-Gault formula or serum creatinine =< 1.5 x upper limit of normal (ULN) Estimated creatinine clearance < 50 mL/min/1.73m^2 (Cockroft-Gault formula) Patients must have either a normal serum creatinine (=< institutional upper limit of normal [IULN]) OR estimated creatinine clearance >= 60 ml/min (Cockcroft-Gault formula) Creatinine =< 1.5 X institutional ULN or calculated creatinine clearance >= 60 ml/min as estimated using the Cockroft-Gault formula Adequate renal function, defined as estimated creatinine clearance >50 mL/min according to Cockcroft-Gault formula or measured 24-hour creatinine clearance (or local institutional standard method). Adequate renal function, defined as estimated creatinine clearance >30 mL/min according to Cockcroft-Gault formula or measured 24-hour creatinine clearance (or local institutional standard method). Estimated creatinine clearance using the Cockcroft-Gault formula must be > 40 mL/minute Estimated (Cockroft-Gault formula) or measured creatinine clearance <40 mL/min Estimated creatinine clearance of >= 30 mL/min, calculated using the formula of Cockroft and Gault Serum creatinine ? 1.5 times ULN and creatinine clearance (CLcr) ? 30 mL/min according to the Cockroft-Gault formula Native kidney function producing creatinine clearance (either measured or estimated by Cockcroft formula) of at least 40 mL/min. Cockcroft formula: CLcr = [(140-age) • wt(kg)]/[72 •Creat (mg/dL)] (For females, multiply by 0.85) Creatinine clearance (Clcr) < 30 mL/minute as estimated using the Cockroft-Gault formula or on dialysis Patients must have adequate renal function as defined by a creatinine clearance >= 40 mL/min (measured or estimated by the Cockcroft-Gault formula) Estimated creatinine clearance of >= 30 mL/min, calculated using the formula of Cockcroft and Gault Creatinine =< 2.0 x ULN OR estimated creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault formula The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m^2 as calculated by the Cockcroft-Gault formula Actual creatinine clearance of < 60 utilizing the Cockroft-Gault formula Estimated (Cockroft-Gault formula) or measured creatinine clearance <40 mL/min Brain malignancy or metastases to the brain Estimated creatinine clearance (for patients > 12 years) greater than 50.0 mL/minute (using the Cockcroft-Gault formula and actual body weight); for pediatric patients (> 1 year to 12 years), Glomerular Filtration Rate (GFR) estimated by the updated Schwartz formula ? 90.0 mL/min/1.73 m^2. If the estimated creatinine clearance is < 90 mL/min/1.73 m^2, then renal function must be measured by 24-hour creatinine clearance or nuclear GFR, and must be > 70.0 mL/min/1.73 m^2. Estimated creatinine clearance >= 30 mL/min via Cockroft-Gault formula Creatinine =< 2.0 x IULN OR estimated creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault formula Estimated creatinine clearance greater than 50 mL/minute (using the Cockcroft-Gault formula and actual body weight) Estimated creatinine clearance greater than 50 mL/minute (using the Cockcroft-Gault formula and actual body weight) Estimated creatinine clearance (CrCl) >= 30 mL/min according to the Cockcroft-Gault formula or local institutional standard method Estimated creatinine clearance >= 30 mL/min according to the Cockcroft-Gault formula serum creatinine ?1.5 X institutional UNL or estimated (Cockcroft-Gault formula) or measured creatinine clearance ? 50 mL/min Serum creatinine =< 1.5 x ULN OR creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula) Creatinine clearance (CrCl) ? 40 mL/min as estimated by the Cockcroft and Gault formula1 in subjects with creatinine > 2 X ULN Creatinine =< 1.5 X ULN or calculated creatinine clearance (CrCl) > 60 mL/min using the Cockcroft-Gault formula less than eight days prior to start of treatment within 14 days of starting cycle 1 day 1 treatment Creatinine clearance (CrCl) >= 30 mL/minute, either measured or calculated using a standard formula (eg, Cockcroft and Gault) Calculated creatinine clearance (CrCl) of ? 50 mL/min by the Cockcroft-Gault formula. Obtained within 14 days prior to C1D1: Serum creatinine =< 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl) >= 40 mL/min calculated using the Cockcroft-Gault formula Calculated creatinine clearance (CrCL) ? 30 mL/minute (using Cockcroft-Gault formula). ARM 2 - A: Calculated GFR > 30 cc/min; creatinine clearance (CrCl) by Cockcroft Gault will be used to estimate GFR CrCl of >= 60 (as calculated by Cockcroft-Gault formula) Serum creatinine ? 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl ? 40 mL/min (if using the Cockcroft-Gault formula) Creatinine clearance (CrCL) >= 60 mL/min/1.73 m^2 calculated by Cockcroft-Gault Serum creatinine ? 1.5 x ULN or CrCl > 60 ml/min (Cockcroft-Gault formula) Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40 mL/min (using the\r\nCockcroft-Gault formula). Creatinine up to 1.5 upper institutional limits OR creatinine clearance (CrCl) > 50 mL/min/1.73 m^2 OR within normal as predicted by the Cockcroft-Gault formula Serum creatinine =< 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl) >= 40 mL/min according to the Cockcroft-Gault formula Creatinine =< 3 X ULN or calculated creatinine clearance (CrCl) > 30 mL/min using Cockcroft- Gault formula Creatinine ? 1.5 x ULN or creatinine clearance (CrCl) ? 40 mL/min (if using the Cockcroft-Gault formula) Obtained within 14 days prior to randomization/registration: serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 50 mL (if using the Cockcroft-Gault formula) Body surface area (BSA)-normalized creatinine clearance >= 60 mL/min/1.73 m^2 (using Cockcroft-Gault creatinine clearance [CrCl]) Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40 mL/min according to the Cockcroft-Gault formula or local institutional standard method Creatinine clearance (CrCl) > 30 mL/min, calculated using the Cockcroft-Gault formula Within 14 days of the first dose of the study drugs: Serum creatinine =< 1.5 x ULN by gender (as long as patient does not require dialysis); May receive transfusion; Without growth factor support (filgrastim or pegfilgrastim) for at least 14 days; If creatinine is not < 1.5 x ULN, then calculate by Cockcroft-Gault methods or local institutional standard and creatinine clearance (CrCl) must be > 30 mL/kg/1.73 m^2. Serum creatinine of =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) > 50 mL/minute (using Cockcroft/Gault formula) within 14 days of study registration. Obtained within 21 days prior to randomization/registration: Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula). Have adequate renal function within 15 days prior to study treatment, defined by the following criteria: Creatinine ? 1.5 x ULN and CrCl ? 30 ml/min per Cockcroft Gault formula: Creatinine clearance (CrCl) >= 40 mL/minute within 21 days prior to start of therapy either measured or calculated using a standard formula (e.g., Cockcroft and Gault) Creatinine clearance (CrCL) > 40 mL/min as measured via Cockcroft-Gault Serum creatinine < 1.5 x ULN or creatinine clearance (CrCl) > 40 mL/min (measured or calculated using the Cockcroft-Gault formula) Serum creatinine =< 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl) >= 40 mL/min (measured or calculated using the Cockcroft-Gault formula) Serum creatinine =< 2 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula) Creatinine clearance > 45 mL/min (or serum creatinine [SCr] =< 1.5 mg/dL), normal within 2 weeks prior to start of treatment; the standard Cockcroft and Gault formula or the measured glomerular filtration rate must be used to calculate creatinine clearance (CrCl) for enrollment or dosing Serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >=30 mL/min (using the Cockcroft-Gault formula) within 14 days prior to first dose Serum creatinine =< 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl) >= 40 mL/min (measured or calculated using the Cockcroft-Gault formula) using actual weight (ideal or adjusted weights are unacceptable) Creatinine clearance of >= 30 mL/min; creatinine clearance (CrCl) should be calculated suing the Cockcroft-Gault formula Calculated creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula) Adequate renal function: serum creatinine =< 2.0 x ULN or creatinine clearance (CrCl) >= 30mL/min obtained within 28 days prior to registration; a calculated creatinine clearance by Cockcroft-Gault formula is acceptable in lieu of a measured value Serum creatinine =< 1.5 X upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40mL/min (if using the Cockcroft-Gault formula) Creatinine =< 1.5 X ULN and creatinine clearance (CrCL) >= 30 ml/min per Cockcroft Gault formula (obtained =< 14 days prior to registration) Creatinine /=40 milliliters per minute (mL/min) or 60 mL/min for those who receive lenalidomide Serum creatinine =< 1.5 x ULN (as long as patient does not require dialysis); a) may receive transfusion b) if creatinine is not < 1.5 x ULN, then calculate by Cockcroft-Gault methods or local institutional standard and creatinine clearance (CrCl) must be >= 40 mL/kg/1.73 m^2 within 14 days prior to study entry Serum creatinine =< 1.5 x ULN OR creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula), within 14 days prior to treatment Serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 50 mL/min should be obtained within 21 days prior to enrollment\r\n* Use the Cockcroft-Gault formula \r\n* Alternatively to Cockcroft-Gault formula of CrCl, 24 hour (hr) urine CrCl can be used Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula) Completed within 60 days of surgery: Calculated creatinine clearance ? 60 mL/min; the creatinine clearance CrCl is determined by the Cockcroft-Gault formula Calculated creatinine clearance (CrCl) or 24-hour urine CrCl > 50 mL/min (Cockcroft-Gault formula will be used to calculate CrCl) (within 14 days prior to registration) Calculated creatinine clearance (CrCl) or 24-hour urine CrCl > 50 mL/min Cockcroft-Gault formula (using actual body weight) will be used to calculate CrCl, except for patients (pts) with osteosarcoma who will be allowed to participate with an estimated creatinine clearance (CrCl) of > 40 mL/min, as calculated by the Cockcroft-Gault equation Creatinine clearance (CrCl) < 60 ml/min by Cockcroft-Gault formula Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft?Gault formula) obtained within 14 days prior to randomization/registration Creatinine =< 1.5 x ULN OR creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula) Creatinine clearance (CrCl) >= 50 mL/min calculated by the Cockcroft-Gault method Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40 mL/min (using the Cockcroft-Gault formula) Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula) Creatinine clearance (CrCl) ? 60 mL/minute (Cockcroft-Gault). INCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: Serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula) Creatinine clearance (CrCl) >= 45 mL/minute within 7 days prior to enrollment either measured or calculated using a standard formula (eg, Cockcroft and Gault); in cases that creatinine clearance cannot be measured accurately, 24 hour urine can be used Creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft?Gault formula) Calculated or measured creatinine clearance (CrCL) >= 60 mL/min using modified Cockcroft and Gault formula A pretreatment creatinine clearance (CrCl) of >= 60 mL/minute (min), calculated by Cockcroft Gault Serum creatinine > 1.5 x ULN and/or creatinine clearance (CrCl) < 30 mL/min at screening (calculation according to Cockcroft & Gault formula) Creatinine clearance (CrCl) >= 30 mL/minute, either measured or calculated using a standard formula (e.g., Cockcroft and Gault) Creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) > 40 mL/min (using the Cockcroft-Gault formula) Serum creatinine ? 2.0 mg/dL OR calculated creatinine clearance (crcl) ? 45 mL/min (if using the Cockcroft-Gault formula) Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula) Serum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula) Creatinine clearance (CrCL) >=60 calculated by Cockroft-Gault Serum creatinine =< 1.5 x ULN OR creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula) Calculated creatinine clearance (CrCl) >= 30 mL/min (Cockcroft-Gault method) Creatinine =< 1.5 x institutional upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40 mL/min using Cockcroft-Gault formula Creatinine clearance (CrCl) ? 15 mL/minute within 7 days prior to randomization,\n either measured or calculated using a standard formula (e.g., Cockcroft and Gault) Calculated creatinine clearance (CrCl) > 50 cc/min/1.73 m^2, using the Cockcroft-Gault equation; note: a measured CrCl from a 24 hour urine collection may also be used Creatinine clearance (calculated creatinine clearance is permitted) < 60 mL/min based on Traditional Cockcroft-Gault formula\r\n* For patients < 18 years: creatinine clearance (CrCl) will be estimated by the Schwartz formula; a measured CrCl or a glomerular filtration rate (GFR) may be substituted to determine the subject’s CrCl Creatinine clearance (CrCl) >= 60 mL/min as calculated by the Cockcroft-Gault method Calculated creatinine clearance (CrCL) ? 30 mL/minute (Cockcroft-Gault formula). Serum creatinine ?1.5 x the ULN and a calculated creatinine clearance (CrCl) ?45 mL/min by the Cockcroft-Gault method. Creatinine clearance (CrCl) < 50 mL/min (Cockcroft-Gault formula) at screening Serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula) Body surface area (BSA)-normalized creatinine clearance >= 30 mL/min/1.73 m^2 (using Cockcroft-Gault creatinine clearance [CrCl]) Serum creatinine =< 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula) Within 14 days prior to registration: serum creatinine less than or equal to the institutional upper limit of normal (ULN) or creatinine clearance (CrCl) >= 60 mL/min (calculated using the Cockcroft-Gault formula) for participants with serum creatinine levels above institutional ULN Serum creatinine < 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) > 30 mL/min (measured or calculated using the Cockcroft-Gault formula) Serum creatinine of < 3.0 x ULN (upper limit of normal) or creatinine clearance (CrCl) > 30 mL/minute (using Cockcroft/Gault formula below) Creatinine clearance >= 50 ml/min; creatinine clearance (CrCl) will be calculated by Cockcroft-Gault method Serum creatinine =< 1.5 x ULN OR creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula) Serum creatinine =< 1.5 mg/dL or calculated creatinine clearance (CrCL) > 60 mL/min using Cockcroft and Gault formula Calculated creatinine clearance (CrCl) > 50 mL/min using Cockcroft-Gault formula The standard Cockcroft and Gault formula or the measured glomerular filtration rate must be used to calculate creatinine clearance (CrCl) for enrollment or dosing Creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula) Serum creatinine =< 2.0 g/dL or calculated creatinine clearance (CrCl) >= 60mL/min (Cockcroft-Gault method) Calculated or measured creatinine clearance (CrCl) rate of ? 30 mL/min calculated using the formula of Cockcroft and Gault [(140 ? age) × mass (kg) / (72 × serum creatinine mg/dL)]. Multiply result by 0.85 if female. Creatinine clearance (CrCl) >= 60 mL/min by Cockcroft-Gault calculation Creatinine clearance (CrCl) >= 50mL/min per Cockcroft-Gault Creatinine clearance (CrCL) >= 40 mL/min as measured via Cockcroft-Gault Creatinine clearance (CrCl) >/= 30 mL/minute within 28 days prior to registration, either measured or calculated using a standard formula (eg, Cockcroft and Gault) Calculated creatinine clearance (CrCl) >= 30 mL/min (Cockcroft-Gault formula), patients with a CrCl >= 15 mL/min can be considered for the trial if patients are not in active renal failure and after discussion with the principal investigator (PI) Serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula) Have adequate renal function as defined by the following criteria: Creatinine ? 1.5 x ULN and CrCl ? 30 ml/min per Cockcroft Gault formula: Creatinine clearance >= 60 ml/min; creatinine clearance (CrCl) can be measured or estimated using Cockcroft-Gault method Adequate renal function as assessed by calculated creatinine using Cockcroft-Gault estimation of creatinine clearance (CrCl); subjects must have calculated CrCl >= 30 ml/min by Cockcroft-Gault formula Serum creatinine =< 2 x upper limit normal (ULN) or creatinine clearance (CrCl) >= 30 mL/min using the Cockcroft-Gault formula Calculated creatinine clearance (CrCl) >= 45mL/min (using Cockcroft & Gault method) Renal: Serum creatinine ? 1.5 x ULN OR calculated creatinine clearance (CrCl) > 30 ml/min as calculated by the Cockcroft-Gault method Creatinine clearance (CrCl) >= 40 mL/min (modified Cockcroft-Gault) Serum creatinine ?1.5 x ULN and a calculate creatinine clearance (CrCl) ?45 mL/min by the Cockcroft-Gault method Serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula) Adequate renal function: serum creatinine <1.5 x ULN or calculated CrCl >60 mL/min using Cockcroft-Gault formula Renal: Serum creatinine ? 1.5 x ULN or creatinine clearance (CrCl) ? 60 ml/min as calculated by the cockcroft-gault method Serum creatinine ? 1.5 × ULN OR calculated creatinine clearance (CrCl) or 24-hour urine CrCl ? 50 mL/minute ? Cockcroft-Gault formula will be used to calculate CrCl; 24-hour urine CrCl will be derived using the measured creatinine clearance formula Creatinine clearance (CrCl) >= 15 mL/minute within 7 days prior to randomization, either measured or calculated using a standard formula (eg, Cockcroft and Gault) Serum Creatinine Clearance(CrCl) ? 30 mL/min, either measured or calculated using a standard formula (e.g. Cockcroft and Gault) Calculated or measured creatinine clearance (CrCl) of ? 15 mL/min within 21 days prior to randomization. Calculation should be based on standard formula such as the Cockcroft and Gault: [(140 - Age) x Mass (kg) / (72 x Creatinine mg/dL)]; multiply result by 0.85 if female. Serum creatinine ? 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) ? 40 mL/min (measured using the Cockcroft-Gault formula) Pemetrexed/cisplatin therapy; note: patients who will receive pemetrexed/cisplatin therapy must meet all eligibility criteria below:\r\n* Patients assigned to pemetrexed/cisplatin therapy must NOT have squamous cell histology\r\n* Calculated creatinine clearance must be obtained within 2 weeks of registration and calculated creatinine clearance (CrCl) must be >= 45mL/min using the standard Cockcroft and Gault formula, or the measured glomerular filtration rate (GFR) using the appropriate radiolabeled method (51-CrEDTA or Tc99m-DTPA) must be used to calculate CrCl Calculated creatinine clearance (CrCl) ? 50 ml/minute (using Cockcroft and Gault's formula; see APPENDIX 2). Serum creatinine =< 1.5 x ULN OR creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula)