Measured creatinine clearance (CL) > 40 mL/min OR calculated creatinine clearance (CL) > 40 mL/min as determined by Cockcroft-Gault (using actual body weight)Xx_NEWLINE_xXSerum creatinine =< 1.5 x ULN OR creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula)Xx_NEWLINE_xXSerum 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 studyXx_NEWLINE_xXCreatinine =< 1.5 mg/dl or creatinine clearance >= 60 cc/min (can be calculated by 24 hour urine or by the Cockroft-Gault formula)Xx_NEWLINE_xXCreatinine =< 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)Xx_NEWLINE_xXWithin 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 weightXx_NEWLINE_xXCalculated creatinine clearance of > 50 mL/min using the Cockcroft-Gault formula, must be obtained within 8 weeks prior to screening for protocol therapyXx_NEWLINE_xXELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Calculated creatinine clearance of > 50 mL/min using the Cockcroft-Gault formulaXx_NEWLINE_xXSerum 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 registrationXx_NEWLINE_xXSerum 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 registrationXx_NEWLINE_xXWithin 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 normalXx_NEWLINE_xXCalculated creatinine clearance must be > 60 ml/min using the Cockcroft-Gault formula within 4 weeks prior to randomizationXx_NEWLINE_xXCalculated (Calc.) creatinine clearance >= 30 mL/min; calculated utilizing the Cockcroft-Gault formula or 24-hour urine collectionXx_NEWLINE_xXRE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Calc. creatinine clearance >= 30 mL/min\r\n* Calculated utilizing the Cockcroft-Gault formula or 24-hour urine collectionXx_NEWLINE_xXCreatinine =< 2.0 mg/dL OR creatinine clearance (calculated clearance permitted) >= 40 mL/min by Cockcroft-Gault formulaXx_NEWLINE_xXSerum 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 registrationXx_NEWLINE_xXCalculated (calc.) creatinine clearance >= 50 mL/min by Cockcroft-GaultXx_NEWLINE_xXCalculated creatinine clearance >= 40 mL/min (Cockcroft-Gault formula)Xx_NEWLINE_xXAdequate renal function defined as creatinine less than or equal to 1.5 X ULN (upper limit of normal) or calculated creatinine clearance greater than or equal to 40 mL/min per the Cockcroft and Gault formula with creatinine levels greater than 1.5 X ULNXx_NEWLINE_xXSerum 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 eligibleXx_NEWLINE_xXCalculated creatinine clearance using cockroft Gault formula >/= 50 mL/min (see Appendix 1)Xx_NEWLINE_xXObtained =< 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 formulaXx_NEWLINE_xXCreatinine clearance > 50 mL/min (calculated according to institutional standards or using Cockcroft-Gault or Modification of Diet in Renal Disease [MDRD] formula)Xx_NEWLINE_xXEstimated 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 standardXx_NEWLINE_xXSerum creatinine =< 1.5 x upper limit of normal (ULN) or calculated creatinine clearance using Cockcroft-Gault formula >= 50 mL/minXx_NEWLINE_xXCalculated creatinine clearance >= 50 mL/min (per the Cockcroft-Gault formula)Xx_NEWLINE_xXSerum 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 C1D1Xx_NEWLINE_xXObtained =< 14 days prior to registration: Calculated creatinine clearance >= 45 ml/min using the Cockcroft-Gault formulaXx_NEWLINE_xXRenal function: Estimated creatinine clearance by Cockcroft-Gault formula ? 45 mL/min.Xx_NEWLINE_xXCreatinine clearance >= 40 mL/min per 24 hour urine collection or the Cockcroft-Gault formulaXx_NEWLINE_xXAcceptable renal function with serum creatinine ? 1.5 x ULN or a calculated creatinine clearance ? 50 mL/min using the Cockcroft-Gault or Modification of Diet in Renal Disease formulas.Xx_NEWLINE_xXAdequate 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.Xx_NEWLINE_xXParticipants 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.Xx_NEWLINE_xXAdequate renal function as demonstrated by serum creatinine ?1.5 x ULN or creatinine clearance>60 mL/min as calculated by the Cockroft and Gault formulaXx_NEWLINE_xXSerum creatinine =< 1.5 x institution's upper limit of normal (ULN), or creatinine clearance >= 30 ml/min (according to Cockroft-Gault formula, or local institutional standard method)Xx_NEWLINE_xXCreatinine clearance >= 60 mL/min by the modified Cockcroft-Gault formula; timeline: within 3 weeks prior to enrollmentXx_NEWLINE_xXAcceptable renal function with serum creatinine ? 1.5 x ULN or a calculated creatinine clearance ? 60 mL/min using the Cockcroft-Gault or Modification of Diet in Renal Disease formulas.Xx_NEWLINE_xXCreatinine ?1.5 mg/dL or calculated creatinine clearance using the Cockcroft-Gault formula ?60 mL/min or measured creatinine clearanceXx_NEWLINE_xXCreatinine =< 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 treatmentXx_NEWLINE_xXCreatinine clearance >= 50 mL/min based either on Cockcroft-Gault estimate or based on urine collection (12 or 24 hour)Xx_NEWLINE_xXAdequate 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 formulaXx_NEWLINE_xXEstimated creatinine clearance >= 70 cc/min (calculated by Cockcroft-Gault formula)Xx_NEWLINE_xXCreatinine clearance > 50 ml/min calculated by the Cockcroft-Gault formulaXx_NEWLINE_xXCreatinine =< 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 eligibleXx_NEWLINE_xXCreatinine clearance (CrCl) >= 30 mL/minute, either measured or calculated using a standard formula (eg, Cockcroft and Gault)Xx_NEWLINE_xXCreatinine < 1.5 x ULN or creatinine clearance > 60 ml/min according to Cockcroft-Gault formulaXx_NEWLINE_xXRenal function assessed by calculated creatinine clearance >= 60 ml/min by Cockcroft-Gault formulaXx_NEWLINE_xXCalculated or measured creatinine clearance of >= 30 mL/minute calculated using the Cockcroft and Gault formulaXx_NEWLINE_xXSerum 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 insteadXx_NEWLINE_xXSerum creatinine =< 1.5 x institutional ULN OR creatinine clearance >= 50 mL/min/1.73 m^2 by Cockcroft-GaultXx_NEWLINE_xXCreatinine =< 1.5 x institutional upper limit of normal OR creatinine clearance >= 50 mL/min as determined by the Cockcroft-Gault formulaXx_NEWLINE_xXCalculated creatinine clearance (CrCl) of ? 50 mL/min by the Cockcroft-Gault formula.Xx_NEWLINE_xXObtained 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 formulaXx_NEWLINE_xXAcceptable renal function, as specified below:: • Creatinine clearance (CrCl) calculated by Cockroft-Gault formula of ? 60 mL/min.Xx_NEWLINE_xXCalculated creatinine clearance ? 30 mL/min (Cockcroft-Gault formula)Xx_NEWLINE_xXAdequate renal function defined as calculated creatinine clearance ?30 milliliters per minute (mL/min) per the Cockcroft and Gault formulaXx_NEWLINE_xXENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: Calculated creatinine clearance (determined as per Cockcroft-Gault) >= 50 mL/minXx_NEWLINE_xXEXPANDED ACCESS COHORT: Creatinine clearance >= 50 mL/min (determined by the Cockcroft-Gault method) for participants with creatinine levels above 1.5 x institutional ULNXx_NEWLINE_xXCreatinine clearance of >= 60 mL/min per the Cockcroft-Gault formulaXx_NEWLINE_xXObtained within 28 days prior to registration: Calculated creatinine clearance >= 60 cc/min (Cockcroft-Gault formula will be used to calculate creatinine clearance)Xx_NEWLINE_xXSerum creatinine clearance > 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearanceXx_NEWLINE_xXCreatinine clearance of >= 30 ml/min; creatinine clearance should be determined by the Cockcroft-Gault formula within 14 days of enrollment to trialXx_NEWLINE_xXCalculated creatinine clearance > 50 mL/min (per the Cockcroft-Gault formula)Xx_NEWLINE_xXSerum creatinine =< 1.5 mg/dL OR measured creatinine clearance (CrCl) >= 45 mL/min as calculated by the Cockcroft-Gault method OR 24-hour measured urine CrCl >= 45 mL/minXx_NEWLINE_xXEstimated creatinine clearance greater than 40 mL/minute (using the Cockcroft-Gault formula and actual body weight)Xx_NEWLINE_xXSerum creatinine < 1.5 mg/dL or calculated creatinine clearance >= 50 mL/min within 30 days prior to registration estimated by the Cockcroft-Gault formulaXx_NEWLINE_xXSerum 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.Xx_NEWLINE_xXEstimated creatinine clearance (CrCl) >= 50 mL/min/1.73 m^2 according to the Cockcroft-Gault formula, within 14 days prior to registrationXx_NEWLINE_xXRenal status: Creatinine clearance ?50 mL/min based on Cockcroft-Gault estimate or based on urine collection (12 or 24 hour);Xx_NEWLINE_xXCreatinine =< 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)Xx_NEWLINE_xXAdequate renal function with normal serum creatinine, or if creatinine above or below institutional normal range, a calculated glomerular filtration rate of ? 50 mL/min/1.73m2 (e.g., as calculated by the Cockcroft Gault formula) using actual body weight; if subject has body mass index > 30 kg/m2, lean body weight must be used.Xx_NEWLINE_xXCreatinine clearance (by Cockcroft Gault formula) <40 mL/minXx_NEWLINE_xXCreatinine 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 formulaXx_NEWLINE_xXAcceptable renal function with serum creatinine ? 1.5 x ULN or a calculated creatinine clearance ? 60 mL/min using the Cockcroft-Gault or Modification of Diet in Renal Disease formulas.Xx_NEWLINE_xXCalculated creatinine clearance >= 50 ml/min using the Cockcroft-Gault formulaXx_NEWLINE_xXCalculated creatinine clearance (using Cockcroft-Gault formula) > 45 mL/min, at the screening visitXx_NEWLINE_xXCalculated creatinine clearance >= 30 mL/min using Cockcroft-Gault formulaXx_NEWLINE_xXCalculated creatinine clearance (CrCL) ? 30 mL/minute (using Cockcroft-Gault formula).Xx_NEWLINE_xXCreatinine clearance > 30 mL/min by Cockcroft-Gault formulaXx_NEWLINE_xXARM 2 - A: Calculated GFR > 30 cc/min; creatinine clearance (CrCl) by Cockcroft Gault will be used to estimate GFRXx_NEWLINE_xXPHASE I: Calculated creatinine clearance (CrCl) >= 60 mL/min calculated by Cockcroft-Gault formulaXx_NEWLINE_xXPHASE IB: Calculated creatinine clearance (CrCl) >= 60 mL/min calculated by Cockcroft-Gault formulaXx_NEWLINE_xXSerum creatinine =< 1.5 x IULN OR creatinine clearance by Cockcroft-Gault >= 30 mL/min/1.73 m^2 for patients with creatinine levels > 1.5 x IULNXx_NEWLINE_xXCreatinine clearance >= 45 ml/min determined by 24-hour collection or estimated by the Cockroft-Gault formulaXx_NEWLINE_xXSerum creatinine =< 1.5 x ULN or calculated creatinine clearance >= 50 ml/min (by Cockroft-Gault formula)Xx_NEWLINE_xXCreatinine clearance >= 45 mL/min calculated by Cockcroft-Gault or 24 hour collectionXx_NEWLINE_xXRenal function: >= 60 ml/min (actual or calculated by the Cockcroft-Gault method) or a creatinine =< the upper limits of normalXx_NEWLINE_xXCreatinine ?1.5 x ULN or creatinine clearance ?40 mL/min as calculated by the Cockcroft-Gault methodXx_NEWLINE_xXCrCl of >= 60 (as calculated by Cockcroft-Gault formula)Xx_NEWLINE_xXSerum creatinine calculated creatinine clearance by the method of Cockcroft and Gault (< 50mL/min)Xx_NEWLINE_xXEstimated creatinine clearance greater than 60 mL/min determined by 24-hour urine sampling or by the Cockcroft- Gault formulaXx_NEWLINE_xXSerum creatinine < 1.5 x upper limit of normal (ULN) or calculated creatinine clearance of >= 45 cc/min using the Cockcroft-Gault formulaXx_NEWLINE_xXCreatinine clearance >= 50 mL/min/1.73 m^2 for patients with creatinine levels above 1.5 x institutional normal (using the Cockcroft Gault formula)Xx_NEWLINE_xXSerum 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.Xx_NEWLINE_xXWithin 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)Xx_NEWLINE_xXCreatinine clearance >= 51 mL/min (calculated using the Cockcroft-Gault formula), =< 5 days prior to C1D1Xx_NEWLINE_xXCalculated creatinine clearance >= 40 mL/min using the Cockcroft-Gault formula obtained within 14 days prior to initiating study treatment.Xx_NEWLINE_xXAdequate 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.Xx_NEWLINE_xXShould 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 clearanceXx_NEWLINE_xXCalculated creatinine clearance >= 40 mL/min (Cockcroft-Gault formula)Xx_NEWLINE_xXEstimated creatinine clearance >= 30 mL/min according to the Cockcroft-Gault formulaXx_NEWLINE_xXCalculated creatinine clearance > 40 mL/min as determined by Cockcroft-Gault (using actual body weight).Xx_NEWLINE_xXSerum creatinine ? 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl ? 40 mL/min (if using the Cockcroft-Gault formula)Xx_NEWLINE_xXRenal function: Estimated creatinine clearance by Cockcroft-Gault formula ? 45 mL/min and serum creatinine ? 2 mg/dLXx_NEWLINE_xXSerum creatinine < 1.5 x ULN or measured creatinine clearance (calculated using Cockcroft-Gault formula) > 40 ml/minXx_NEWLINE_xXCreatinine clearance (CrCL) >= 60 mL/min/1.73 m^2 calculated by Cockcroft-GaultXx_NEWLINE_xXSerum creatinine ? 1.5 x ULN or CrCl > 60 ml/min (Cockcroft-Gault formula)Xx_NEWLINE_xXPatients 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 formulaXx_NEWLINE_xXSubject 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 formulaXx_NEWLINE_xXCreatinine clearance ? 30 ml/min by Cockcroft-Gault formulaXx_NEWLINE_xXSerum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40 mL/min (using the\r\nCockcroft-Gault formula).Xx_NEWLINE_xXCreatinine 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 formulaXx_NEWLINE_xXCisplatin-ineligible as defined by at least one of the following:\r\n* Calculated creatinine clearance >= 30 but =< 60 mL/min (Cockcroft-Gault)\r\n* ECOG performance status of 2 or greater\r\n* CTCAE v4 grade >= 2 audiometric hearing lossXx_NEWLINE_xXObtained within 28 days prior to registration: Calculated creatinine clearance >= 30 but =< 60 mL/min (Cockcroft-Gault)Xx_NEWLINE_xXWithin 7 days of enrollment and with 24 h of starting lymphodepleting chemotherapy: Calculated creatinine clearance (Cockcroft-Gault) >= 50.0 mL/min.Xx_NEWLINE_xXWithin 28 days prior to registration: Calculated creatinine clearance >= 40 mL/min\r\n* Cockcroft-Gault formula will be used to calculate creatinine clearanceXx_NEWLINE_xXCreatinine 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 therapyXx_NEWLINE_xXCreatinine clearance (by Cockcroft Gault formula) greater than or equal to 50 mL/minXx_NEWLINE_xXAn estimated creatinine clearance > 30 mL/min according to the Cockcroft-Gault formula or be measure for creatinine clearance from 24-hour urine collection.Xx_NEWLINE_xXCockcroft-Gault calculated creatinine clearance of >= 45 ml/min or creatinine =< 1.5 x ULN obtained =< 14 days prior to study initiationXx_NEWLINE_xXCreatinine clearance >=50 mL/min based either on Cockcroft-Gault estimate or based on urine collection (12 or 24 hour).Xx_NEWLINE_xXCreatinine within normal institutional limits OR, creatinine clearance > 40 mL/min by Cockcroft-Gault or 24h urine collection.Xx_NEWLINE_xXAdequate renal function as defined by calculated creatinine clearance =< 60 mL/min (Cockcroft-Gault formula)Xx_NEWLINE_xXSerum creatinine =< 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl) >= 40 mL/min according to the Cockcroft-Gault formulaXx_NEWLINE_xXCreatinine clearance > 50mls/min (calculated with Cockroft-Gault formula);Xx_NEWLINE_xXCreatinine =< 3 X ULN or calculated creatinine clearance (CrCl) > 30 mL/min using Cockcroft- Gault formulaXx_NEWLINE_xXCreatinine clearance >= 40 ml/min as determined by 24-hour collection or estimated by the Cockcroft-Gault formula (measured within 28 days of registration)Xx_NEWLINE_xXSerum creatinine =< 1.5 X institutional ULN or creatinine clearance > 40 ml/min as calculated by the Cockcroft-Gault formulaXx_NEWLINE_xXCreatinine ? 1.5 x ULN or creatinine clearance (CrCl) ? 40 mL/min (if using the Cockcroft-Gault formula)Xx_NEWLINE_xXEstimated creatinine clearance (eClCR) >45 mL/min (with eCLCR to be calculated by the Cockcroft-Gault formula, orXx_NEWLINE_xX(** = calculated by Cockcroft and Gault's formula)Xx_NEWLINE_xXObtained 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)Xx_NEWLINE_xXAdequate renal function defined by an estimated creatinine clearance >= 40 mL/min according to the Cockcroft-Gault formula (or local institutional standard method).Xx_NEWLINE_xXWithin 28 days prior to administration of study treatment: Creatinine clearance >= 51 mL/min, calculated using Cockcroft-Gault formulaXx_NEWLINE_xXParticipant 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.Xx_NEWLINE_xXObtained 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 formulaXx_NEWLINE_xXSerum 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 clearanceXx_NEWLINE_xXSerum creatinine of =< 1.5 X ULN or creatinine clearance > 40 mL/minute (using Cockcroft/Gault formula)Xx_NEWLINE_xXSerum 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 methodXx_NEWLINE_xXSerum creatinine =< 1.5 x the upper limit of normal (ULN) or calculated creatinine clearance (by Cockcroft-Gault formula) >= 60 mL/minXx_NEWLINE_xXCalculated creatinine clearance > 40 cc/min by the modified Cockcroft-Gault formula for adults or the Schwartz formula for pediatricsXx_NEWLINE_xXCreatinine > 1.5 x within normal institutional ULN OR creatinine clearance >= 40 mL/min (using Cockcroft-Gault formula) for participants with creatinine levels above institutional ULNXx_NEWLINE_xXAdequate 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 collectionXx_NEWLINE_xXCreatinine clearance (CrCl) > 30 mL/min, calculated using the Cockcroft-Gault formulaXx_NEWLINE_xXCreatinine =< 1.5 x ULN and requires creatinine clearance (CrCl) >= 60ml/min (per 24-hour urine collection or calculated according to the Cockcroft-Gault formula)Xx_NEWLINE_xXEstimated creatinine clearance ? 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method)Xx_NEWLINE_xXSubjects must have adequate renal function with a creatinine clearance of >= 40 mL/min as determined by the Cockcroft-Gault calculationXx_NEWLINE_xXSerum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/minXx_NEWLINE_xXObtained =< 14 days prior to registration: Calculated creatinine clearance must be >= 45 ml/min using the Cockcroft-Gault formulaXx_NEWLINE_xXCreatinine clearance >= 50 ml/min by Cockcroft-Gault formula or 24 hour urinary clearanceXx_NEWLINE_xXSerum 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 clearanceXx_NEWLINE_xXWithin 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.Xx_NEWLINE_xXEstimated creatinine clearance >= 30 mL/min according to the Cockcroft-Gault formulaXx_NEWLINE_xXSerum 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 registrationXx_NEWLINE_xXCalculated 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)Xx_NEWLINE_xXSerum creatinine =< 2 mg/dL, or calculated creatinine clearance > 50 mL/min (per the Cockcroft-Gault formula)Xx_NEWLINE_xXCalculated creatinine clearance of >= 60 cc/min using the Cockcroft-Gault formulaXx_NEWLINE_xXCreatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearanceXx_NEWLINE_xXSerum 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.Xx_NEWLINE_xXRenal 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 1Xx_NEWLINE_xXObtained 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).Xx_NEWLINE_xXHave 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:Xx_NEWLINE_xXCreatinine clearance > 30 mL/min by Cockcroft-Gault formulaXx_NEWLINE_xXCreatinine 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)Xx_NEWLINE_xXSerum creatinine =< 2 x upper limit of normal (ULN) or estimated creatinine clearance >/=30 ml/min as calculated using the Cockcroft-Gault formula.Xx_NEWLINE_xXSerum creatinine =< mg/dl or creatinine clearance (CC) >= 50 ml/min determined by 24 hour collection or estimated by Cockcroft-Gault formulaXx_NEWLINE_xXSerum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearanceXx_NEWLINE_xXCreatinine clearance >= 40 mL/min/1.73 m^2 by the Cockcroft-Gault formulaXx_NEWLINE_xXSerum 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.Xx_NEWLINE_xXhave adequate renal function, defined as having a serum creatinine ?1.5 × ULN and a creatinine clearance ?40mL/min (estimated using the Cockcroft-Gault formula);Xx_NEWLINE_xXCreatinine clearance (CrCl) >= 30 mL/min., as measured by a 24-hour urine collection, or estimated by the Cockcroft and Gault formulaXx_NEWLINE_xXEstimated creatinine clearance ? 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method)Xx_NEWLINE_xXNo 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 clearanceXx_NEWLINE_xXEstimated creatinine clearance >= 30 ml/min (calculated according using Cockcroft–Gault formula)Xx_NEWLINE_xXCreatinine ?1.5 times the ULN and calculated creatinine clearance >60 mL/min (by Cockcroft Gault formula; see Appendix B);Xx_NEWLINE_xXSerum creatinine ? 1.5 times the ULN or creatinine clearance > 30 mL/min by Cockcroft-Gault formulaXx_NEWLINE_xXCreatinine clearance (CrCL) > 40 mL/min as measured via Cockcroft-GaultXx_NEWLINE_xXSTUDY TREATMENT: Creatinine clearance of 20 ml/min or greater as measured by the Cockroft-Gault formulaXx_NEWLINE_xXSerum creatinine < 1.5 x ULN or creatinine clearance (CrCl) > 40 mL/min (measured or calculated using the Cockcroft-Gault formula)Xx_NEWLINE_xXSerum creatinine =< 1.5 mg/dL, or calculated (using the formula of Cockcroft and Gault) or measured creatinine clearance >= 30 mL/minXx_NEWLINE_xXSerum 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 clearanceXx_NEWLINE_xXWithin 14 days of the first study treatment: Creatinine clearance >= 30 mL/min by Cockcroft-Gault formula (or local institutional standard method)Xx_NEWLINE_xXCreatinine =< 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/minXx_NEWLINE_xXAdequate 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)Xx_NEWLINE_xXWithin 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 estimationXx_NEWLINE_xXSerum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearanceXx_NEWLINE_xXEstimated creatinine clearance of < 30 mL/min, calculated using the formula of Cockcroft and Gault at the time of screeningXx_NEWLINE_xXPatients 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)Xx_NEWLINE_xXSerum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formulaXx_NEWLINE_xXCalculated creatinine clearance >= 50 ml/min (using Cockcroft-Gault method)Xx_NEWLINE_xXWithin 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 formulaXx_NEWLINE_xXCreatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearanceXx_NEWLINE_xXPatients 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 registrationXx_NEWLINE_xXCockcroft calculated creatinine clearance of >= 45 ml/min or 1.5 x the upper limit of normal (ULN)Xx_NEWLINE_xXSerum creatinine =< 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl) >= 40 mL/min (measured or calculated using the Cockcroft-Gault formula)Xx_NEWLINE_xXSerum creatinine =< 2 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula)Xx_NEWLINE_xXSerum 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 clearanceXx_NEWLINE_xXCreatinine clearance > 30 mL/min (calculated according to institutional standards or using Cockcroft–Gault formula)Xx_NEWLINE_xXcreatinine clearance ? 60 mL/min (Cockroft & Gault formula);Xx_NEWLINE_xXSerum 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 registrationXx_NEWLINE_xXSerum creatinine =< 1.5 x ULN or creatinine clearance (calculated with the Cockcroft-Gault formula) >= 40 mL/min, within 30 days before study registrationXx_NEWLINE_xXCreatinine 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 dosingXx_NEWLINE_xXSerum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >=30 mL/min (using the Cockcroft-Gault formula) within 14 days prior to first doseXx_NEWLINE_xXSerum creatinine =< 1.5 x age-adjusted upper limit of normal (ULN) or calculated creatinine clearance (Cockcroft and Gault) > 30 mL/min/1.73 m^2Xx_NEWLINE_xXAcceptable 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).Xx_NEWLINE_xXSerum 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)Xx_NEWLINE_xXSerum creatinine =< 1.5 mg/dL and /or calculated creatinine clearance (using Cockcroft-Gault formula) >= 30 mL/minXx_NEWLINE_xXSerum 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 clearanceXx_NEWLINE_xXSerum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/minXx_NEWLINE_xXCreatinine clearance >= 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method)Xx_NEWLINE_xXCalculated creatinine clearance must be >= 45 ml/min using the Cockcroft-Gault formula obtained =< 7 days prior to registrationXx_NEWLINE_xXCreatinine clearance >= 30 mL/min according to the Cockcroft-Gault formulaXx_NEWLINE_xXObtained 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)Xx_NEWLINE_xXParticipant 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.Xx_NEWLINE_xXSerum creatinine > 1.5 x upper limit of normal (ULN) or creatinine clearance < 40 mL/min (measured or calculated by Cockroft-Gault formula)Xx_NEWLINE_xXCreatinine clearance (Cockroft-Gault calculated or 24-hour urine) >= 30 mL/minXx_NEWLINE_xXEstimated creatinine clearance >= 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method)Xx_NEWLINE_xXCreatinine clearance of >= 30 mL/min; creatinine clearance (CrCl) should be calculated suing the Cockcroft-Gault formulaXx_NEWLINE_xXCalculated creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula)Xx_NEWLINE_xXAdequate 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 valueXx_NEWLINE_xXSerum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance.Xx_NEWLINE_xXSerum creatinine =< 1.5 X upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40mL/min (if using the Cockcroft-Gault formula)Xx_NEWLINE_xXCreatinine =< 1.5 X ULN and creatinine clearance (CrCL) >= 30 ml/min per Cockcroft Gault formula (obtained =< 14 days prior to registration)Xx_NEWLINE_xXCreatinine =< 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)Xx_NEWLINE_xXCreatinine </=2.0 milligrams per deciliter (mg/dL), with creatinine clearance (CrCl) using the Cockcroft-Gault formula >/=40 milliliters per minute (mL/min) or 60 mL/min for those who receive lenalidomideXx_NEWLINE_xXSerum creatinine ?1.5 x ULN or creatinine clearance ?50 mL/min based on either urine collection or Cockcroft Gault estimation.Xx_NEWLINE_xXSerum 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 clearanceXx_NEWLINE_xXCreatinine 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.Xx_NEWLINE_xXSerum 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 registrationXx_NEWLINE_xXCreatinine clearance >= 50 mL/min based either on Cockroft-Gault estimate or based on urine collection (12 or 24 hour)Xx_NEWLINE_xXSerum 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 entryXx_NEWLINE_xXTo 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 neededXx_NEWLINE_xXWithin 14 days prior to planned start of treatment: Creatinine clearance of >= 60 mL/min per the Cockcroft-Gault formulaXx_NEWLINE_xXSerum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearanceXx_NEWLINE_xXSerum 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)Xx_NEWLINE_xXCreatinine =< 1.5 x ULN OR creatinine clearance >= 50 mL/min calculated using the formula of Cockcroft and GaultXx_NEWLINE_xXCreatinine clearance >= 50 mL/min based either on Cockcroft-Gault estimate or based on urine collection (12 or 24 hour)Xx_NEWLINE_xXSerum creatinine =< 1.5 x ULN OR creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula), within 14 days prior to treatmentXx_NEWLINE_xXCreatinine 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 areaXx_NEWLINE_xXAdequate 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 formulaXx_NEWLINE_xXSerum 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 usedXx_NEWLINE_xXSerum creatinine clearance >= 50 ml/min (calculated with Cockcroft-Gault formula)Xx_NEWLINE_xXEstimated creatinine clearance >= 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method)Xx_NEWLINE_xXRenal 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 TPFXx_NEWLINE_xXSerum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula)Xx_NEWLINE_xXSerum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearanceXx_NEWLINE_xXSerum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearanceXx_NEWLINE_xXThe patient has serum creatinine clearance ?50 mL/min by the Cockcroft-Gault formula.Xx_NEWLINE_xXCreatinine clearance (CrCl) >= 50 mL/min calculated by the Cockroft-GaultXx_NEWLINE_xXCreatinine =< 2.0 mg/dL OR calculated creatinine clearance >= 50 mL/min (as calculated by the Cockcroft-Gault method)Xx_NEWLINE_xXCreatinine clearance >= 40 mL/min for patients with creatinine\r\n* Levels above institutional normal (calculated using the Cockcroft-Gault formula)Xx_NEWLINE_xXObtained =< 14 days prior to randomization: Calculated creatinine clearance must be >= 45 ml/min using the Cockcroft-Gault formulaXx_NEWLINE_xXCreatinine =< 1.5 x ULN or creatinine clearance > 50 mL/min (calculated by Cockcroft-Gault method)Xx_NEWLINE_xXSerum creatinine >= 1.5 x upper limit of normal (ULN) and creatinine clearance (by Cockcroft-Gault formula) < 60 mL/minXx_NEWLINE_xXCompleted within 60 days of surgery: Calculated creatinine clearance ? 60 mL/min; the creatinine clearance CrCl is determined by the Cockcroft-Gault formulaXx_NEWLINE_xXCalculated 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)Xx_NEWLINE_xXFor 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)Xx_NEWLINE_xXSerum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearanceXx_NEWLINE_xXCalculated 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 equationXx_NEWLINE_xXCreatinine > 1.5 x ULN, or a creatinine clearance of < 60 ml/min as calculated by Cockcroft-Gault or by 24-hour urine collectionXx_NEWLINE_xXCreatinine clearance (by Cockcroft Gault formula or measured) >= 50 mL/minXx_NEWLINE_xXCreatinine < 1.5 mg/dL OR creatinine clearance (by Cockcroft Gault formula) >= 50 mL/minXx_NEWLINE_xXWithin 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 clearanceXx_NEWLINE_xXEstimated (by Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] or Cockgroft-Gault equations) or calculated creatinine clearance (CrCl) >= 40 ml/minXx_NEWLINE_xXPHASE I: Creatinine =< ULN OR creatinine clearance >= 51 mL/min (calculated using the Cockcroft-Gault formula) for patients with creatinine levels above institutional normalXx_NEWLINE_xXPHASE II SCLC: Creatinine =< ULN OR creatinine clearance >= 51 mL/min (calculated using the Cockcroft-Gault formula) for patients with creatinine levels above institutional normalXx_NEWLINE_xXUROTHELIAL CARCINOMA EXPANSION COHORT: Creatinine =< ULN OR creatinine clearance >= 51 mL/min (calculated using the Cockcroft-Gault formula) for patients with creatinine levels above institutional normalXx_NEWLINE_xXmCRPC EXPANSION COHORT: Creatinine =< ULN OR creatinine clearance >= 51 mL/min (calculated using the Cockcroft-Gault formula) for patients with creatinine levels above institutional normalXx_NEWLINE_xXCreatinine clearance > 50 mL/min (calculated according to institutional standards or using Cockcroft-Gault, Modification of Diet in Renal Disease [MDRD], or Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula)Xx_NEWLINE_xXSerum creatinine =< 1.5 x upper limit of normal (ULN) or estimated creatinine clearance >= 60 ml/min per modified Cockcroft-Gault formulaXx_NEWLINE_xXSerum creatinine =< 1.5 times the ULN, or calculated creatinine clearance >= 50 mL/minute (per the Cockcroft-Gault formula)Xx_NEWLINE_xXSerum creatinine =< 1.5 x mg/dL and/or calculated creatinine clearance (using Cockcroft-Gault formula) >= 30 mL/minXx_NEWLINE_xXCreatinine clearance >= 50 mL/min based either on Cockroft-Gault estimate or based on urine collection (12 or 24 hour)Xx_NEWLINE_xXSerum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinineXx_NEWLINE_xXRenal: 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)Xx_NEWLINE_xXSerum creatinine < 1.5 x ULN or creatinine clearance > 50 mL/min (by Cockcroft- Gault)Xx_NEWLINE_xXCreatinine clearance >= 50 mL/min (calculated using the Cockroft-Gault formula or measured with 24 hour urine collection)Xx_NEWLINE_xXSerum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearanceXx_NEWLINE_xXNormal serum creatinine, or a creatinine clearance >= 40 ml/min (either measured using a 24 hour urine, calculated using Cockroft-Gault, or estimated using the Modification of Diet in Renal Disease [MDRD] method from the National Kidney Disease Education Program [NKDEP] [the method reported by M D Anderson Cancer Center (MDACC) laboratories])Xx_NEWLINE_xXCreatinine ? 1.5 x the upper limit of normal (ULN), or calculated creatinine clearance ? 60 mL/minute x 1.73 m2 per the Cockcroft-Gault formulaXx_NEWLINE_xXCreatinine clearance (CrCl) < 60 ml/min by Cockcroft-Gault formulaXx_NEWLINE_xXCreatinine clearance (based on modified Cockcroft-Gault formula) ? 45 ml/min.Xx_NEWLINE_xXSerum 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 formulaXx_NEWLINE_xXplasma creatinine ? 1.5 x upper limit of normal (ULN) for the institution or calculated clearance ? 60 mL/min (Cockcroft-Gault formula)Xx_NEWLINE_xXRenal function assessed by calculated creatinine clearance: \r\n* Calculated creatinine clearance >=30 ml/min by Cockcroft-Gault formulaXx_NEWLINE_xXCreatinine clearance >= 50 mL/min based either on Cockcroft-Gault estimate from serum creatinine or based on urine collection (12 or 24 hour)Xx_NEWLINE_xXCreatinine =< 1.5 mg/dL × ULN, or calculated creatinine clearance (determined as per Cockcroft-Gault)Xx_NEWLINE_xXCreatinine < 1.5 mg/dl and/or creatinine clearance > 60 mL/min using the Cockcroft-Gault formulaXx_NEWLINE_xXCreatinine within normal institutional limits OR creatinine clearance >= 50 mL/min based on the standard Cockcroft and Gault formula obtained within 14 days of first treatmentXx_NEWLINE_xXSerum 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/registrationXx_NEWLINE_xXCreatinine =< 1.5 x ULN OR creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula)Xx_NEWLINE_xXCreatinine clearance (CrCl) >= 50 mL/min calculated by the Cockcroft-Gault methodXx_NEWLINE_xXSerum 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 clearanceXx_NEWLINE_xXSerum 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 formulaXx_NEWLINE_xXWithin 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 clearanceXx_NEWLINE_xXAdequate 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.Xx_NEWLINE_xXSerum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40 mL/min (using the Cockcroft-Gault formula)Xx_NEWLINE_xXSerum creatinine < 1.5 mg/dL and/or calculated creatinine clearance (using Cockcroft-Gault formula) >= 30 mL/minXx_NEWLINE_xXEstimated 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 utilizedXx_NEWLINE_xXCalculated creatinine clearance >= 30 mL/min; Cockcroft-Gault formula will be used to calculate\r\ncreatinine clearanceXx_NEWLINE_xXPHASE I: Subjects must have calculated creatinine clearance >= 60 ml/min by Cockcroft-Gault formula, obtained =< 7 days prior to registrationXx_NEWLINE_xXPHASE II: Subjects must have calculated creatinine clearance >= 30 ml/min by Cockcroft-Gault formula, obtained =< 7 days prior to registrationXx_NEWLINE_xXEstimated creatinine clearance ? 30mL/min (Cockcroft-Gault formula)Xx_NEWLINE_xXSerum 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/minXx_NEWLINE_xXWithin 14 days prior to study entry: Calculated creatinine clearance >= 40 mL/min using Cockcroft-Gault formulaXx_NEWLINE_xXCalculated creatinine clearance (CrCl) >= 50 mL/min per 24 hour urine collection or the Cockcroft-Gault formulaXx_NEWLINE_xXCalculated creatinine clearance (CrCl) >= 30 mL/min per 24-hour urine collection or the Cockcroft-Gault formulaXx_NEWLINE_xXCreatinine =< 1.5 x ULN OR calculated creatinine clearance >= 60 mL/min calculated by the Cockcroft-Gault formulaXx_NEWLINE_xXAdequate 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)Xx_NEWLINE_xXARM A COHORT 1: Creatinine =< 1.5 x institutional ULN, or creatinine clearance >= 50 mL/min (calculated with the Cockcroft-Gault formula)Xx_NEWLINE_xXARM B COHORT 2: Creatinine =< 1.5 x institutional ULN, or creatinine clearance >= 50 mL/min (calculated with the Cockcroft-Gault formula)Xx_NEWLINE_xXARM B COHORT 3: Creatinine =< 1.5 x institutional ULN, or creatinine clearance >= 50 mL/min (calculated with the Cockcroft-Gault formula)Xx_NEWLINE_xXARM C COHORT 4: Creatinine =< 1.5 x institutional ULN, or creatinine clearance >= 50 mL/min (calculated with the Cockcroft-Gault formula)Xx_NEWLINE_xXCreatinine =< 1.5 mg/dL or creatinine clearance by Cockcroft-Gault formula >= 60 mL/minXx_NEWLINE_xXEither 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 collectionXx_NEWLINE_xXCreatinine ? 1.5x the upper limit of normal (ULN), or calculated creatinine clearance ? 60 mL/minute x 1.73 m^2 per the Cockcroft-Gault formulaXx_NEWLINE_xXCreatinine =< 2.0 x ULN (for patients with > 1.5 x ULN, calculated or measured creatinine clearance must be = 40 mL/minute [Cockcroft-Gault]).Xx_NEWLINE_xXSerum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula)Xx_NEWLINE_xXAdequate renal function: calculated creatinine clearance > 30 ml/min (Cockcroft-Gault)Xx_NEWLINE_xXSerum creatinine clearance >= 50 ml/min (calculated by Cockroft-Gault formula)Xx_NEWLINE_xXSerum creatinine =< 1.5 times the upper limit of normal or creatinine clearance > 30 mL/min by Cockcroft-Gault formulaXx_NEWLINE_xXCreatinine clearance (CrCl) ? 60 mL/minute (Cockcroft-Gault).Xx_NEWLINE_xXCalculated creatinine clearance of < 30 mL/min using Cockcroft Gault or measured by 24 hour urineXx_NEWLINE_xXCreatinine clearance >= 30 mL/min by Cockcroft-Gault formulaXx_NEWLINE_xXCalculated creatinine clearance must be >= 50 ml/min using the Cockcroft-Gault formulaXx_NEWLINE_xXSerum 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 formulaXx_NEWLINE_xX24 hour creatinine clearance or calculated (using the Cockcroft-Gault formula) creatinine clearance > 60 mL/min/1.73 m^2 (induction phase only)Xx_NEWLINE_xXRESEARCH 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)Xx_NEWLINE_xXMust 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 GaultXx_NEWLINE_xXINCLUSION 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)Xx_NEWLINE_xXCreatinine clearance > 30 mL/min (calculated according to institutional standards or using Cockcroft–Gault formula; subjects with requirement of hemodialysis will be excluded)Xx_NEWLINE_xXCreatinine 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 usedXx_NEWLINE_xXCreatinine =< 1.5 x ULN OR creatinine clearance >= 50 mL/min calculated using the formula of Cockcroft and GaultXx_NEWLINE_xXSerum creatinine < 1.5 mg/dL and/or calculated creatinine clearance (using Cockcroft-Gault formula) >= 30 mL/minXx_NEWLINE_xXSerum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 60 mL/min OR 24-hour urine creatinine clearance >= 60 mL/minXx_NEWLINE_xXCalculated creatinine clearance >= 50 mL/min (calculated by the Cockcroft-Gault formula), obtained within 30 days of study registration, orXx_NEWLINE_xXCreatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft?Gault formula)Xx_NEWLINE_xXPART 2: Calculated creatinine clearance using the Cockcroft-Gault formula or 24 hr urine creatinine clearance must be > 60 ml/minXx_NEWLINE_xXWithin 21 days prior to C1D1: Estimated creatinine clearance of >= 30 mL/min, calculated using the formula of Cockcroft and GaultXx_NEWLINE_xXCalculated or measured creatinine clearance (CrCL) >= 60 mL/min using modified Cockcroft and Gault formulaXx_NEWLINE_xXCreatinine clearance (CC) >= 50 ml/min within 4 weeks prior to registration determined by 24-hour collection or estimated by Cockcroft-Gault formulaXx_NEWLINE_xXSerum 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 formulaXx_NEWLINE_xXAdequate renal function as defined by: calculated creatinine clearance must be >= 40 mL/minute (Cockcroft-Gault)Xx_NEWLINE_xXA pretreatment creatinine clearance (CrCl) of >= 60 mL/minute (min), calculated by Cockcroft GaultXx_NEWLINE_xXCreatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/minXx_NEWLINE_xXCreatinine clearance (calculated by the Cockroft-Gault formula) >= 30 ml/minXx_NEWLINE_xXCreatinine clearance of >= 50 mL/min (estimated by the Cockcroft-Gault [C-G] formula)Xx_NEWLINE_xXSerum creatinine > 1.5 x ULN and/or creatinine clearance (CrCl) < 30 mL/min at screening (calculation according to Cockcroft & Gault formula)Xx_NEWLINE_xXSerum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/minXx_NEWLINE_xXCreatinine clearance (CrCl) >= 30 mL/minute, either measured or calculated using a standard formula (e.g., Cockcroft and Gault)Xx_NEWLINE_xXCreatinine > 1.5 times the upper limit of normal (ULN) (unless creatinine clearance normal), or calculated creatinine clearance < 40 mL/min (using Cockcroft-Gault formula)Xx_NEWLINE_xXThe estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m^2 as calculated by the Cockcroft-Gault FormulaXx_NEWLINE_xXSerum 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 formulaXx_NEWLINE_xXCreatinine clearance < 60 mL/min (calculated by Cockcroft-Gault formula)Xx_NEWLINE_xXPatients 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.Xx_NEWLINE_xXSerum creatinine clearance equal or more than 50 ml/min (calculated with Cockcroft-Gault formula)Xx_NEWLINE_xXCreatinine within normal institutional limits OR creatinine clearance >= 50 mL/min/1.73 m^2 by Cockcroft-Gault formulaXx_NEWLINE_xXCalculated creatinine clearance by Cockcroft-Gault formula >= 30 ml/min obtained within 2 weeks prior to registrationXx_NEWLINE_xXRANDOMIZED PHASE II (ARMS K AND L): Calculated creatinine clearance by Cockroft-Gault formula >= 30 ml/min, obtained within 2 weeks prior to registrationXx_NEWLINE_xXCalculated creatinine clearance according to the formula of Cockroft and Gault >= 50 mL/minXx_NEWLINE_xXSubjects must have adequate renal function with a creatinine clearance of >= 40 mL/min as determined by the Cockcroft-Gault calculationXx_NEWLINE_xXEstimated serum creatinine clearance >= 60 ml/min (using the Cockroft-Gault formula and/or serum creatinine =< 1.6 mg/dLXx_NEWLINE_xXEstimated serum creatinine clearance >= 50 ml/min (using the Cockcroft-Gault formula)Xx_NEWLINE_xXCreatinine < 1.5 x ULN or creatinine clearance > 60 ml/min according to Cockroft-Gault formulaXx_NEWLINE_xXSerum creatinine =< 2 mg/dl or creatinine clearance >= 40 ml/min (creatinine clearance calculated per Cockroft-Gault formula or by 24-hour urine collection), within 14 days prior to study entryXx_NEWLINE_xXCreatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) > 40 mL/min (using the Cockcroft-Gault formula)Xx_NEWLINE_xXPatients 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 weekXx_NEWLINE_xXSerum creatinine ? 1.5 x ULN and/or creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 50 mL/minXx_NEWLINE_xXObtained =< 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 analysisXx_NEWLINE_xXSerum creatinine < 2x normal, or creatinine clearance (as determined by the Schwartz formula Cockcroft and Gault) > 40ml/min/m^2 or 70ml/minXx_NEWLINE_xXSerum creatinine > 2.0 mg/dL or 177 ?mol/L or creatinine clearance < 40 mL/min (using the Cockcroft-Gault formula)Xx_NEWLINE_xXCreatinine =< 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 registrationXx_NEWLINE_xXCreatinine 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 clearanceXx_NEWLINE_xXEstimated creatinine clearance > 30 mL/min according to the Cockcroft-Gault formulaXx_NEWLINE_xXCalculated creatinine clearance of >= 50 cc/min using the Cockcroft-Gault formulaXx_NEWLINE_xXAdequate 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.)Xx_NEWLINE_xXCreatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 45 mL/minXx_NEWLINE_xXEstimated creatinine clearance of >= 30 mL/min, calculated using the formula of Cockcroft and GaultXx_NEWLINE_xXCalculated creatinine clearance of >= 55 cc/min using the Cockcroft-Gault formulaXx_NEWLINE_xXRenal function: >= 60 ml/min (actual or calculated by the Cockcroft-Gault method)Xx_NEWLINE_xXCreatinine 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 trialXx_NEWLINE_xXSerum creatinine ? 2.0 mg/dL OR calculated creatinine clearance (crcl) ? 45 mL/min (if using the Cockcroft-Gault formula)Xx_NEWLINE_xXRenal: 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.Xx_NEWLINE_xXSerum creatinine =< 1.5 x ULN, or measured creatinine clearance (CrCl) >= 45 mL/min as calculated by the Cockcroft-Gault method or 24-hour measured urine CrCl >= 45 mL/minXx_NEWLINE_xXWithin 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 labXx_NEWLINE_xXSerum creatinine =< 2 mg/dL. The Cockcroft-Gault formula will be used to calculate creatinine clearance in all subjects.Xx_NEWLINE_xXTo 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 formulaXx_NEWLINE_xXCreatinine ? 1.5 x the upper limit of normal (ULN), or calculated creatinine clearance ? 50 mL/minute x 1.73 m2 per the Cockcroft-Gault formulaXx_NEWLINE_xXCreatinine clearance >60 mL/min (calculated using the Cockcroft-Gault formula) or by 24-hours urine collectionXx_NEWLINE_xXObtained ? 14 days prior to registration: calculated creatinine clearance must be ? 30 ml/min using the Cockcroft Gault formulaXx_NEWLINE_xXMeasured 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 clearanceXx_NEWLINE_xXSeverely impaired renal function, defined as creatinine clearance (CrCl) ? 30 mL/min estimated by the Cockcroft-Gault formulaXx_NEWLINE_xXSerum 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 treatmentXx_NEWLINE_xXCreatinine ? 1.5 x upper limits of normal (ULN) OR calculated creatinine clearance ? 60 mL/min by Cockcroft-Gault formulaXx_NEWLINE_xXSerum 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.Xx_NEWLINE_xXWithin 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 formulaXx_NEWLINE_xXObtained =< 21 days prior to registration: Creatinine =< 1.0 mg/dL or creatinine clearance >= 45 ml/min using the Cockcroft-Gault formulaXx_NEWLINE_xXSerum creatinine clearance (CL) >40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance.Xx_NEWLINE_xXSerum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearanceXx_NEWLINE_xXCreatinine clearance >= 50 mL/min (calculated by the Cockcroft-Gault or via 24-hour urine collection)Xx_NEWLINE_xXSerum 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/minuteXx_NEWLINE_xXCalculated creatinine clearance must be >= 30 ml/min using the Cockcroft-Gault formulaXx_NEWLINE_xXEstimated creatinine clearance > 40 mL/min by the Cockcroft-Gault formulaXx_NEWLINE_xXSerum creatinine value < upper limit of normal (ULN) or creatinine clearance of >= 60 mL/min according to Cockgroft?Gault formulaXx_NEWLINE_xXCreatinine Clearance >= 60 mg/mL as calculated by the modified Cockraft-Gault formulaXx_NEWLINE_xXTo 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 formulaXx_NEWLINE_xXEstimated (Cockcroft-Gault formula) or measured creatinine clearance <40 mL/min.Xx_NEWLINE_xXSerum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/minXx_NEWLINE_xXWithin 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 clearanceXx_NEWLINE_xXCreatinine within normal institutional limits OR creatinine clearance >= 30 Ml/min (Cockcroft-Gault formula or measured with 24 hour [h] urine)Xx_NEWLINE_xXCreatinine clearance (CrCl) >= 50 ml/min within 14 days prior to registration as determined by 24-hour collection or estimated by Cockcroft-Gault formulaXx_NEWLINE_xXSerum 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 therapyXx_NEWLINE_xXCreatinine clearance >= 50; creatinine clearance must be calculated using Cockroft-Gault formulaXx_NEWLINE_xXSerum 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 formulaXx_NEWLINE_xXSerum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula)Xx_NEWLINE_xXSerum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula)Xx_NEWLINE_xXCalculated creatinine clearance must be >= 50 ml/min using the Cockcroft-Gault formula, obtained =< 14 days prior to registrationXx_NEWLINE_xXCreatinine clearance (CrCL) >=60 calculated by Cockroft-GaultXx_NEWLINE_xXObtained 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 clearanceXx_NEWLINE_xXCreatinine clearance > 60 mL/min/1.73 m^2 by either Cockcroft-Gault formula or 24-hour urine collection analysisXx_NEWLINE_xXSerum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearanceXx_NEWLINE_xXSerum creatinine =< 1.5 x institutional ULN (Cockcroft and Gault formula)Xx_NEWLINE_xXSerum creatinine =< 1.5 x ULN OR creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula)Xx_NEWLINE_xXSerum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/minXx_NEWLINE_xXSerum creatinine < 2 x institutional ULN or creatinine clearance > 50 ml/min as determined by 24 hour collection or estimated by Cockcroft-Gault formulaXx_NEWLINE_xXCreatinine =< 2.0 mg/dL, OR calculated creatinine clearance >= 30 mL/min (calculated by the Cockcroft and Gault method)Xx_NEWLINE_xXSerum creatinine =< ULN or calculated creatinine clearance >= 35 mL/min using Cockcroft-Gault formulaXx_NEWLINE_xXCreatinine clearance of >= 45 mL/min per 24 hour urine collection or the Cockcroft-Gault formulaXx_NEWLINE_xXCreatinine =< 1.5 x ULN OR calculated creatinine clearance >= 50 ml/min using the Cockcroft-Gault formula (obtained =< 14 days prior to registration)Xx_NEWLINE_xXPatients must have a serum creatinine =< the IULN OR measured or calculated creatinine clearance >= 50 mL/min using the Cockroft-Gault formulaXx_NEWLINE_xXCalculated creatinine clearance (CrCl) >= 30 mL/min (Cockcroft-Gault method)Xx_NEWLINE_xXCreatinine clearance > 30 cc/min calculated using the Cockcroft and Gault (1976) formula or measuredXx_NEWLINE_xXCreatinine clearance >= 30 by Cockcroft-Gault formulaXx_NEWLINE_xXEstimated creatinine clearance of >= 30 mL/min, calculated using the formula of Cockcroft and GaultXx_NEWLINE_xXSerum 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/minXx_NEWLINE_xXCreatinine clearance >= 45 ml/min determined by 24-hour collection or estimated by the Cockroft-Gault formulaXx_NEWLINE_xXCreatinine =< 1.5 x institutional upper limit of normal (ULN) or creatinine clearance (CrCl) >= 40 mL/min using Cockcroft-Gault formulaXx_NEWLINE_xXSerum 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 registrationXx_NEWLINE_xXCreatinine clearance >= 50 mL/min by either Cockcroft-Gault formulate or 24 hour (hr) urine collection analysisXx_NEWLINE_xXCreatinine clearance >= 30 mL/min according to Cockcroft-Gault formulaXx_NEWLINE_xXCreatinine =< 1.5 ULN or calculated creatinine clearance >= 50 mL/min or 24-hour urine creatinine clearance >= 50 mL/min; calculated by the Cockcroft-Gault formulaXx_NEWLINE_xXSerum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/minXx_NEWLINE_xXCreatinine =< 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/minXx_NEWLINE_xXSerum creatinine =< 1.5 × ULN, OR calculated creatinine clearance >= 30 mL/minute (modified Cockcroft and Gault formula)Xx_NEWLINE_xXCreatinine 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)Xx_NEWLINE_xXCreatinine =< 1.5 times the upper limit of normal with creatinine clearance >= 50 mL/min using the modified Cockcroft-Gault methodXx_NEWLINE_xXCreatinine clearance >= 50 ml/min within 2 weeks prior to registration as determined by 24-hour collection or estimated by Cockcroft-Gault formulaXx_NEWLINE_xXCreatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above ULN as calculated by Cockcroft-GaultXx_NEWLINE_xXFor 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 recordedXx_NEWLINE_xXCreatinine =< 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 valueXx_NEWLINE_xXSerum creatinine =< 1.5 x ULN or 24-hour clearance >= 50 mL/min or calculated glomerular filtration rate (GFR) of 60cc/ml using the formula of Cockcroft and GaultXx_NEWLINE_xXRenal 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 valuesXx_NEWLINE_xXCreatinine 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 CrClXx_NEWLINE_xXCalculated 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 formulaXx_NEWLINE_xXSerum creatinine < 1.5 times the ULN, or creatinine clearance > 60 mL/minute as calculated by the standard Cockcroft-Gault formulaXx_NEWLINE_xXCreatinine 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 valuesXx_NEWLINE_xXCreatinine =< 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 clearanceXx_NEWLINE_xXSerum creatinine levels <= 1.5 * ULN, or calculated (by Cockcroft-Gault formula or other accepted formula) or measure creatinine clearance >=50 mL/min.Xx_NEWLINE_xXCreatinine clearance (CrCl) >= 60 mL/min as calculated by the Cockcroft-Gault methodXx_NEWLINE_xXSerum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/minXx_NEWLINE_xXPatients must have a serum creatinine =< the IULN AND measured or calculated creatinine clearance >= 60 cc/min using the Cockroft-Gault formulaXx_NEWLINE_xXREGISTRATION #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 formulaXx_NEWLINE_xXPatients must have a serum creatinine =< the IULN OR measured or calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault formulaXx_NEWLINE_xXAdequate renal function as evidenced by calculated creatinine clearance ? 30 millimeter/ minute (mL/min) according to the Cockcroft and Gault formula.Xx_NEWLINE_xXEstimated 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.Xx_NEWLINE_xXCreatinine 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.Xx_NEWLINE_xXSerum creatinine < 2 x institutional ULN or; creatinine clearance (CC) >= 50 mL/min determined by 24-hour collection or estimated by Cockcroft-Gault formulaXx_NEWLINE_xXSerum creatinine =< 2.0 g/dL or calculated creatinine clearance >= 60 mL/min (Cockcroft-Gault method)Xx_NEWLINE_xXSerum 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),Xx_NEWLINE_xXCreatinine clearance >= 60 mL/min/1.73 m^2 as calculated by Cockcroft-GaultXx_NEWLINE_xXCalculated creatinine clearance >= 40 mL/min (Cockcroft-Gault formula)Xx_NEWLINE_xXCreatinine clearance >= 30 mL/minute (calculated by Cockcroft-Gault formula)Xx_NEWLINE_xXCreatinine clearance < 30 mL/minute (calculated by Cockcroft-Gault formula)Xx_NEWLINE_xXCreatinine 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 registrationXx_NEWLINE_xXRenal function assessed by calculated creatinine clearance (CrCl) must be >= 60 ml/min by Cockcroft-Gault formulaXx_NEWLINE_xXSubjects must have calculated creatinine clearance >= 30ml/min by Cockcroft-Gault formulaXx_NEWLINE_xXCalculated creatinine clearance (CrCL) ? 30 mL/minute (Cockcroft-Gault formula).Xx_NEWLINE_xXCreatinine clearance > 30 ml/min calculated by modified Cockcroft-Gault formulaXx_NEWLINE_xXAdequate renal function defined as calculated creatinine clearance greater than or equal to 30 mL/min per the Cockcroft and Gault formula.Xx_NEWLINE_xXCreatinine clearance >= 40 mL/min/1.73 m^2 by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearanceXx_NEWLINE_xXSerum creatinine ?1.5 x the ULN and a calculated creatinine clearance (CrCl) ?45 mL/min by the Cockcroft-Gault method.Xx_NEWLINE_xXCalculated creatinine clearance < 45mL/min (0.75 mL/sec)using Cockroft-Gault formulaXx_NEWLINE_xXCreatinine clearance (CrCl) < 50 mL/min (Cockcroft-Gault formula) at screeningXx_NEWLINE_xXCreatinine: =< 1.5 mg/dL, OR calculated creatinine clearance >= 40 mL/min (calculated by the modified Cockcroft and Gault method)Xx_NEWLINE_xXCreatinine clearance (estimated) >= 50 cc/min by Cockcroft Gault or 24 hour urineXx_NEWLINE_xXCreatinine =< 2.0 x IULN OR estimated creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault formulaXx_NEWLINE_xXSerum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance > 40 mL/minute (using Cockcroft/Gault formula)Xx_NEWLINE_xXCreatinine clearance >= 40 mL/min\r\n* To be calculated by modified Cockcroft-Gault formulaXx_NEWLINE_xXSerum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault method) >= 50 mL/minute within 14 days prior to treatmentXx_NEWLINE_xXAdequate renal function defined as creatinine clearance greater than 40 mL/min calculated per the Cockcroft and Gault formulaXx_NEWLINE_xXCalculated creatinine clearance by Cockroft-Gault formula >= 30 mL/min obtained within 4 weeks prior to registrationXx_NEWLINE_xXCalculated creatinine clearance by Cockroft-Gault formula >= 30 ml/minXx_NEWLINE_xXSerum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula)Xx_NEWLINE_xXCalculated creatinine clearance must be >= 50 ml/min using the Cockcroft-Gault formula obtained =< 7 days prior to registrationXx_NEWLINE_xX(** = calculated by Cockcroft and Gault's formula)Xx_NEWLINE_xXCreatinine clearance >= 30 mL/min as calculated by Cockcroft-Gault formula within 4 weeks of pre-registrationXx_NEWLINE_xXSerum creatinine > 1.5 x upper limit of normal (ULN) and/or creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 50 mL/minXx_NEWLINE_xXSerum creatinine =< 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula)Xx_NEWLINE_xXSerum 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).Xx_NEWLINE_xXPatients 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 treatmentXx_NEWLINE_xXWithin 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 ULNXx_NEWLINE_xXCalculated creatinine clearance must be >= 50 ml/min using the Cockcroft-Gault formula or a 24 hour urine obtained =< 7 days prior to randomizationXx_NEWLINE_xXSerum creatinine < 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) > 30 mL/min (measured or calculated using the Cockcroft-Gault formula)Xx_NEWLINE_xXWithin 72 h of initiating study treatment: Creatinine =< 1.5 x upper limit of normal (ULN) OR calculated creatinine clearance >= 60 mL/min for subject with creatinine levels > 1.5 x ULN (Cockcroft and Gault)Xx_NEWLINE_xXSerum 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 treatmentXx_NEWLINE_xXSerum creatinine of < 3.0 x ULN (upper limit of normal) or creatinine clearance (CrCl) > 30 mL/minute (using Cockcroft/Gault formula below)Xx_NEWLINE_xXCreatinine clearance >= 50 ml/min; creatinine clearance (CrCl) will be calculated by Cockcroft-Gault methodXx_NEWLINE_xXSerum creatinine < 2.0 mg/dL or calculated creatinine clearance (CrCl) > 45 mL/min (Cockcroft-Gault)Xx_NEWLINE_xXCreatinine clearance > 30 ml/min calculated by modified Cockcroft-Gault formulaXx_NEWLINE_xXCalculated creatinine clearance (by Cockroft-Gault) of > 50 ml/minXx_NEWLINE_xXCreatinine clearance > 30 mL/min (calculated according to Cockcroft - Gault formula) unless due to lymphoma with documentation of normal function prior to onset of lymphomaXx_NEWLINE_xXSerum creatinine (sCr) =< 1.5 x ULN, or creatinine clearance (Ccr) >= 40 mL/min as calculated by the modified Cockcroft-Gault formulaXx_NEWLINE_xXCreatinine clearance > 30 cc/min calculated using the Cockcroft and Gault (1976) formula or measuredXx_NEWLINE_xXAdequate renal function: calculated creatinine clearance > 30 ml/min (Cockcroft-Gault)Xx_NEWLINE_xXSerum 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).Xx_NEWLINE_xXRenal insufficiency (serum creatinine levels > 2.5 mg/dL, calculated creatinine clearance [Crcl] with Cockcroft-Gault formula, < 45 ml/min)Xx_NEWLINE_xXSerum creatinine, ? 1.5x Institutional Upper Limit of Normal (ULN), or Creatinine Clearance ? 50 mL/min (by Cockcroft-Gault formula)Xx_NEWLINE_xXSerum creatinine of =< 1.5 X upper limit of normal (ULN) or creatinine clearance > 40 mL/minute (using Cockcroft/Gault formula)Xx_NEWLINE_xXCreatinine clearance > 50 ml/min, calculated using the formula of Cockcroft and GaultXx_NEWLINE_xXSerum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/minXx_NEWLINE_xXRenal 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 valuesXx_NEWLINE_xXKnown dihydropyrimidine dehydrogenase (DPD) deficiency or severe renal impairment (creatinine clearance < 30 mL/min by Cockcroft-Gault formula)Xx_NEWLINE_xXPhase 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 formulaXx_NEWLINE_xXSerum creatinine ? 1.5 x ULN or calculated creatinine clearance (using Cockcroft and Gault method) > 60 mL/min)Xx_NEWLINE_xXSerum creatinine =< 1.5 x ULN OR creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula)Xx_NEWLINE_xXSerum creatinine =< 1.5 x ULN; or calculated creatinine clearance >= 50 mL/min (using Cockcroft Gault formula); or measured creatinine clearance >= 50 mL/minXx_NEWLINE_xXCreatinine clearance greater than or equal to 30 mL/min to less than 45 ml/min (calculated by Cockcroft-Gault formula)Xx_NEWLINE_xXSubject must have adequate renal function as demonstrated by a creatinine clearance greater than or equal to 30 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula. Note: Investigators should consider measuring a 24-hour creatinine clearance for subjects who are morbidly obese, have fluctuating renal function, or who in the investigator's clinical judgment may yield a more accurate clearance when measured than when calculated.Xx_NEWLINE_xXSerum creatinine =< 1.5 mg/dL or calculated creatinine clearance (CrCL) > 60 mL/min using Cockcroft and Gault formulaXx_NEWLINE_xXCreatinine clearance >= 40 ml/min as determined by 24-hour collection or estimated by the Cockcroft-Gault formulaXx_NEWLINE_xXCalculated creatinine clearance (CrCl) > 50 mL/min using Cockcroft-Gault formulaXx_NEWLINE_xXCreatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance >= 30 mL/min (Cockcroft-Gault calculation)Xx_NEWLINE_xXCreatinine =< 2.5 mg/dL OR calculated creatinine clearance >= 50 mL/min (as calculated by the Cockcroft-Gault method)Xx_NEWLINE_xXCreatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula)Xx_NEWLINE_xXCreatinine clearance > 30 mL/min (calculated according to institutional standards or using Cockcroft–Gault formula; subjects with requirement of hemodialysis will be excluded)Xx_NEWLINE_xXCalculated creatinine clearance must be >= 45 ml/min using the Cockcroft-Gault formulaXx_NEWLINE_xXPatients must be ineligible for treatment with cisplatin, based on one of:\r\n* Calculated creatinine clearance (CrCl) >= 30 and < 60 mL/min (Cockcroft-Gault)\r\n* CTCAE grade (Gr) >= 2 hearing loss\r\n* CTCAE Gr >= 2 neuropathyXx_NEWLINE_xXSerum creatinine < 1.5 mg/dL or calculated creatinine clearance >= 50 mL/min within 30 days prior to registration estimated by the Cockcroft-Gault formulaXx_NEWLINE_xXCalculated creatinine clearance >= 30 mL/min by Cockcroft-Gault within 14 days before enrollmentXx_NEWLINE_xXSerum creatinine clearance >= 50 ml/min by the Cockcroft-Gault formulaXx_NEWLINE_xXCreatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/minXx_NEWLINE_xXEstimated creatinine clearance of >= 50 mL/min, calculated using the formula of Cockroft and GaultXx_NEWLINE_xXSerum creatinine =< 2.0 g/dL or calculated creatinine clearance (CrCl) >= 60mL/min (Cockcroft-Gault method)Xx_NEWLINE_xXCreatinine clearance > 50 mL/minute within 30 days prior to cycle 1 day 1, either measured or calculated using a standard formulaXx_NEWLINE_xXCalculated creatinine clearance of >= 40 ml/min; as per Cockcroft-Gault formulaXx_NEWLINE_xXSerum creatinine =< 3.0 mg/dL or a calculated creatinine clearance of at least 15 mL/min (using the Cockcroft and Gault method)Xx_NEWLINE_xXAcceptable renal function defined as serum creatinine ? 1.5 times ULN or calculated creatinine clearance ? 60mL/min (by Cockcroft Gault formula)Xx_NEWLINE_xXCreatine 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 studyXx_NEWLINE_xXSubject'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.Xx_NEWLINE_xXCreatinine 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 valuesXx_NEWLINE_xXSerum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/minXx_NEWLINE_xXAdequate renal function as evidenced by calculated creatinine clearance > 30 ml/min according to the Cockcroft and Gault formula or by 24 hour urine creatinine clearanceXx_NEWLINE_xXCreatinine clearance >= 60 ml/min using the Cockcroft-Gault method, Modification of Diet in Renal Disease (MDRD), or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. If the calculated creatinine clearance (CrCl) based on Cockcroft-Gault method, MDRD, or CKD-EPI is < 60 mL/min, patient will have a 24 hour (hr) urine collection to measure CrCl.Xx_NEWLINE_xXAdequate 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)Xx_NEWLINE_xXSerum 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 registrationXx_NEWLINE_xXSerum creatinine =< 1.5 x upper limit of normal (ULN) or creatinine clearance of >= 40 mL/min by Cockcroft-Gault formulaXx_NEWLINE_xXCreatinine clearance > 50 mL/minute within 7 days of time of consent, either measured or calculated using a standard formula (e.g., Cockcroft and Gault)Xx_NEWLINE_xXCalculated creatinine clearance must be > 60 mL/min (by Cockcroft-Gault)Xx_NEWLINE_xXCalculated creatinine clearance must be > 60 ml/min using the Cockcroft-Gault formulaXx_NEWLINE_xXCreatinine clearance of ? 50 mL/min (measured or calculated using the Cockcroft and Gault formula)Xx_NEWLINE_xXAdequate renal function, defined as calculated creatinine clearance greater than 40 mL/min per the Cockcroft and Gault formula.Xx_NEWLINE_xXSerum creatinine =< 1.5 mg/dL or creatinine clearance > 45 mL/min; use either measured or calculated with Cockcroft-Gault formulaXx_NEWLINE_xXCalculated 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.Xx_NEWLINE_xXCreatinine =< 1.5 mg/dL or calculated creatinine clearance >= 40 mL/min per the Cockcroft and Gault formulaXx_NEWLINE_xXCalculated or measured creatinine clearance of >= 50 mL/minute, calculated using the formula of Cockcroft and GaultXx_NEWLINE_xXRenal 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 formulaXx_NEWLINE_xXCreatinine =< 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/minXx_NEWLINE_xXRenal function: >= 60 ml/min (actual or calculated by the Cockcroft-Gault method) or a creatinine =< the upper limits of normalXx_NEWLINE_xXEstimated creatinine clearance < 50 mL/min/1.73m^2 (Cockroft-Gault formula)Xx_NEWLINE_xXHave a creatinine clearance of >= 90 ml/min, as calculated by the Cockroft-Gault formulaXx_NEWLINE_xXCreatinine < 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 formulaXx_NEWLINE_xXCalculated creatinine clearance must be > 40 mL/min (by Cockcroft-Gault)Xx_NEWLINE_xXCreatinine within normal institutional limits OR creatinine clearance > 40 mL/min per 24 hour (h) urine collection or calculated according to the Cockcroft-Gault formulaXx_NEWLINE_xXPatients must have either a normal serum creatinine (=< institutional upper limit of normal [IULN]) OR estimated creatinine clearance >= 60 ml/min (Cockcroft-Gault formula)Xx_NEWLINE_xXCreatinine =< 1.5 X institutional ULN or calculated creatinine clearance >= 60 ml/min as estimated using the Cockroft-Gault formulaXx_NEWLINE_xXCreatinine clearance (CrCL) >= 40 mL/min as measured via Cockcroft-GaultXx_NEWLINE_xXPatients must have calculated creatinine clearance >= 60 ml/min by Cockcroft-Gault formula or 24 hour urine demonstrating creatinine clearance (CrCl) >= 60 ml/minXx_NEWLINE_xXCockcroft-Gault calculated creatinine clearance of >= 45 ml/min or creatinine =< 1.5 x ULN obtained =< 14 days prior to randomizationXx_NEWLINE_xXRenal function assessed by calculated creatinine clearance >= 30ml/min by Cockcroft-Gault formulaXx_NEWLINE_xXCalculated creatinine clearance ? 30 ml/min by Cockcroft-Gault formula • Total bilirubin < = 2 x ULNXx_NEWLINE_xXSerum creatinine >1.5x ULN or creatinine clearance <40 mL/min (Cockroft-Gault formula) Exclusion Criteria for Arm S and Arm P only:Xx_NEWLINE_xXAdequate renal function as defined by: calculated creatinine clearance must be at least 40 mL/minute (Cockcroft-Gault)Xx_NEWLINE_xXSerum creatinine =< 2.5 mg/dL or a calculated creatinine clearance of at least 50 mL/min (using the Cockcroft and Gault method)Xx_NEWLINE_xXAdequate 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.Xx_NEWLINE_xXCreatinine clearance (CrCl) >/= 30 mL/minute within 28 days prior to registration, either measured or calculated using a standard formula (eg, Cockcroft and Gault)Xx_NEWLINE_xXAdequate renal function Serum Creatinine <=ULN or Creatinine Clearance calculated by Cockcroft and Gault's formula > 60 mL/minXx_NEWLINE_xXCreatinine clearance >= 30 mL/min as measured using either the Cockcroft-Gault method or 24-hour creatinine clearanceXx_NEWLINE_xXCalculated 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)Xx_NEWLINE_xXCalculated creatinine clearance (Cockroft-Gault) >= 30ml/minXx_NEWLINE_xXCreatinine clearance >= 60 ml/min as determined by 24-hour urine; if a 24-hour urine is not available, the Cockroft-Gault formula will be used for a calculated creatinine clearanceXx_NEWLINE_xXCalculated creatinine clearance >= 60 ml/min (by Cockroft-Gault formula) within 30 days prior to registrationXx_NEWLINE_xXSerum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula)Xx_NEWLINE_xXCalculated creatinine clearance > 30 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearanceXx_NEWLINE_xXSerum 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 clearanceXx_NEWLINE_xXAdequate 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).Xx_NEWLINE_xXAdequate 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).Xx_NEWLINE_xX=< 10 days prior to enrollment/randomization: Creatinine =< 1.5 mg/dL or creatinine clearance >= 50 mL/min calculated by the Cockcroft-Gault methodXx_NEWLINE_xXHave adequate renal function as defined by the following criteria: Creatinine ? 1.5 x ULN and CrCl ? 30 ml/min per Cockcroft Gault formula:Xx_NEWLINE_xXAdequate hepatic and renal function laboratory values within 14 days prior to registration: Calculated (Cockcroft and Gault formula) or measured creatinine clearance >= 30 mL/minXx_NEWLINE_xXSerum creatinine clearance > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearanceXx_NEWLINE_xXCalculated 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 formulaXx_NEWLINE_xXCreatinine < ULN OR calculated creatinine clearance >= 50 mL/min\r\n* Creatinine clearance should be calculated by Cockcroft and Gault methodXx_NEWLINE_xXCalculated creatinine clearance >= 60 mL/min calculated by the Cockcroft-Gault formulaXx_NEWLINE_xXAdequate renal function Serum Creatinine <=ULN or Creatinine Clearance calculated by Cockcroft and Gault's formula > 60 mL/min.Xx_NEWLINE_xXCalculated creatinine clearance > 50 ml/min using Cockcroft-Gault formulaXx_NEWLINE_xXAdequate 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 formulaXx_NEWLINE_xXCalculated (method of Cockroft-Gault) creatinine clearance <60 mL/min.Xx_NEWLINE_xXAll 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.Xx_NEWLINE_xXSerum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 60 mL/minXx_NEWLINE_xXSubjects with creatinine clearance <40 mL/minute at Screening, as calculated by the Cockcroft-Gault formula.Xx_NEWLINE_xXPatients must have adequate renal function defined as creatinine clearance of >= 30 ml/minute (Cockcroft-Gault)Xx_NEWLINE_xXSerum creatinine clearance (CL) >= 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearanceXx_NEWLINE_xXSerum creatinine =< 2 x upper limit normal (ULN) or creatinine clearance (CrCl) >= 30 mL/min using the Cockcroft-Gault formulaXx_NEWLINE_xXCalculated creatinine clearance must be >= 30 mL/minute based on Cockcroft-Gault formulaXx_NEWLINE_xXCalculated creatinine clearance (CrCl) >= 45mL/min (using Cockcroft & Gault method)Xx_NEWLINE_xXRenal: Serum creatinine ? 1.5 x ULN OR calculated creatinine clearance (CrCl) > 30 ml/min as calculated by the Cockcroft-Gault methodXx_NEWLINE_xXCalculated by Cockcroft-Gault or measured by 24 hour urine creatinine clearance >= 50 mL/minnXx_NEWLINE_xXCreatinine within normal institutional limits OR creatinine clearance >= 30 mL/min calculated using the formula of Cockcroft and GaultXx_NEWLINE_xXCreatinine clearance > 30 ml/min (Cockcroft-Gault formula using ideal body weight)Xx_NEWLINE_xXSerum creatinine =< 1.5 x the ULN or calculated creatinine clearance >= 50 ml/min using Cockcroft-Gault formulaXx_NEWLINE_xXSerum 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).Xx_NEWLINE_xXSerum creatinine =< 1.5 x ULN or 24-hour creatinine clearance > 60 mL/min (measured or calculated by Cockcroft-Gault method)Xx_NEWLINE_xXCreatinine clearance >= 30 ml/min or calculated creatinine clearance >= 30 ml/min according to the Cockcroft-Gault formulaXx_NEWLINE_xXA calculated creatinine clearance (Cockcroft Gault) of >= 30 ml/minXx_NEWLINE_xXCalculated (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)Xx_NEWLINE_xXEstimated creatinine clearance using the Cockcroft-Gault formula must be > 40 mL/minuteXx_NEWLINE_xXCreatinine clearance (CrCl) >= 40 mL/min (modified Cockcroft-Gault)Xx_NEWLINE_xXSerum creatinine ?1.5 x ULN and a calculate creatinine clearance (CrCl) ?45 mL/min by the Cockcroft-Gault methodXx_NEWLINE_xXCalculated creatinine clearance (Cockcroft-Gault formula) of >= 45 mL/minXx_NEWLINE_xXSerum creatinine ?1.5 x upper limit of normal (ULN) or creatinine clearance >60 mL/min calculated using Cockcroft-GaultXx_NEWLINE_xXCalculated creatinine clearance >= 40 mL/min/1.73 m^2 based on Cockcroft and Gault methodXx_NEWLINE_xXCreatinine =< 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 usedXx_NEWLINE_xXSerum creatinine < 1.5 mg/dL or calculated creatinine clearance >= 50 ml/min (by Cockcroft-Gault formula) within 14 days prior to registrationXx_NEWLINE_xXCreatinine =< 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)Xx_NEWLINE_xXCreatinine clearance >/=30 milliliters per minute (mL/min) (calculated using the Cockcroft-Gault formula)Xx_NEWLINE_xXSerum 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 randomizationXx_NEWLINE_xXCalculated creatinine clearance (Cockcroft-Gault formula) > 50 ml/min OR 24-hour urine creatinine clearance > 50 ml/minXx_NEWLINE_xXPlasma creatinine =< 1.5 x ULN or creatinine clearance > 50 mL/min (calculated by Cockcroft-Gault method)Xx_NEWLINE_xXCreatinine clearance (CrCl) of greater than or equal to 40 mL/min. using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula; if the CrCl based on the CKD-EPI formula is < 40 mL/min, the patient will have a 24 hour (hr) urine collection to measure CrCl; the measured CrCl must also be >= 40 ml/minXx_NEWLINE_xXAdequate 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.Xx_NEWLINE_xXEstimated (Cockroft-Gault formula) or measured creatinine clearance <40 mL/minXx_NEWLINE_xXCreatinine < 1 X institutional upper limit of normal OR creatinine clearance >= 50 mL/min determined by Cockcroft-Gault formulaXx_NEWLINE_xXCreatinine clearance > 30 mL/min (calculated according to institutional standards or using Cockcroft–Gault formula), +/- 7 days from date of ICF signingXx_NEWLINE_xXCreatinine =< 1.5 x ULN OR creatinine clearance >= 40 mL/min/1.73 m^2 (calculated using the Chronic Kidney Disease-Epidemiology Collaboration [CKD-EPI] equation or Cockroft-Gault formula) for patients with creatinine levels above institutional normalXx_NEWLINE_xXCalculated creatinine clearance must be >= 50 ml/min using the Cockcroft-Gault formulaXx_NEWLINE_xXSerum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 40 mL/min (if using the Cockcroft-Gault formula)Xx_NEWLINE_xXSerum creatinine =< 1.5 x upper limit of normal (ULN) or calculated creatinine clearance >= 60 cc/min using the Cockcroft-Gault formulaXx_NEWLINE_xXCalculated creatinine clearance must be >= 50 ml/min using the applicable Cockcroft-Gault formulaXx_NEWLINE_xXAdequate renal function: serum creatinine <1.5 x ULN or calculated CrCl >60 mL/min using Cockcroft-Gault formulaXx_NEWLINE_xXSerum creatinine ? 1.5 × upper limit of normal (ULN) or creatinine clearance > 40 mL/minute (using Cockcroft/Gault formula)Xx_NEWLINE_xXCreatinine < 1.5 times the upper limit of normal (ULN) or creatinine clearance > 40 mL/min (as measured or calculated by Cockroft-Gault formula)Xx_NEWLINE_xXCreatinine ? 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) ? 50 mL/min OR 24-hour urine creatinine clearance ? 50 mL/minXx_NEWLINE_xXRenal: Serum creatinine ? 1.5 x ULN or creatinine clearance (CrCl) ? 60 ml/min as calculated by the cockcroft-gault methodXx_NEWLINE_xXEstimated creatinine clearance of >= 30 mL/min, calculated using the formula of Cockroft and GaultXx_NEWLINE_xXCalculated creatinine clearance greater than 45 mg/dl using the Cockcroft-Gault formulaXx_NEWLINE_xXMeasured 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.Xx_NEWLINE_xXSerum creatinine > 1.5 x upper limit of normal (ULN); if creatinine 1.0-1.5 x ULN, creatinine clearance, calculated according to Cockcroft-Gault formula, < 60 ml/min will exclude the patientXx_NEWLINE_xXRenal 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)Xx_NEWLINE_xXSerum 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 formulaXx_NEWLINE_xXCreatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/minXx_NEWLINE_xXSerum creatinine ? 1.5 times ULN and creatinine clearance (CLcr) ? 30 mL/min according to the Cockroft-Gault formulaXx_NEWLINE_xXSerum creatinine =< 2 mg/dL or a calculated creatinine clearance of >= 50 mL/min (using the Cockcroft and Gault method)Xx_NEWLINE_xXRenal 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;Xx_NEWLINE_xXClinical 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.Xx_NEWLINE_xXPatients must have adequate renal function, defined as serum creatinine <= 1.5 x upper limit of normal (ULN) for the institution or a calculated creatinine clearance [Cockcroft-Gault method] must be >= 60 mL/min/1.73 m^2).Xx_NEWLINE_xXSerum 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/minuteXx_NEWLINE_xXAdequate 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).Xx_NEWLINE_xXCalculated creatinine clearance >= 30 ml/min by Cockcroft-Gault formulaXx_NEWLINE_xXCreatinine clearance (CrCl) >= 15 mL/minute within 7 days prior to randomization, either measured or calculated using a standard formula (eg, Cockcroft and Gault)Xx_NEWLINE_xXCreatinine* < 2.0 g/dl *or a calculated creatinine clearance > 45/cc (using Cockroft-Gault formula)Xx_NEWLINE_xXSerum 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 collectionXx_NEWLINE_xXPatient must not have known dihydropyrimidine dehydrogenase (DPD) deficiency or severe renal impairment (creatinine clearance below 30 mL/min by Cockcroft and Gault formula) as this would prelude use of capecitabineXx_NEWLINE_xXCalculated creatinine clearance ? 45 mL using the Cockcroft and Gault MethodXx_NEWLINE_xXSerum Creatinine Clearance(CrCl) ? 30 mL/min, either measured or calculated using a standard formula (e.g. Cockcroft and Gault)Xx_NEWLINE_xXCohort A: Calculated creatinine clearance >= 40 mL/min for patients receiving pemetrexed (by Cockcroft-Gault)Xx_NEWLINE_xXCohort A: Calculated creatinine clearance >= 30 mL/min for patients receiving gemcitabine or paclitaxel (by Cockcroft-Gault)Xx_NEWLINE_xXCreatinine =< 1.5 mg/dL or creatinine clearance >= 50 mL/min calculated by the Cockcroft-Gault methodXx_NEWLINE_xXCalculated 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.Xx_NEWLINE_xXCreatinine =< 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 formulaXx_NEWLINE_xXNative 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)Xx_NEWLINE_xXSerum creatinine =< 1.5 x ULN OR creatinine clearance >= 50 mL/min (Cockcroft-Gault calculation)Xx_NEWLINE_xXCalculated creatinine clearance >= 60ml/min by Cockcroft-Gault formulaXx_NEWLINE_xXRenal impairment as determined by a creatinine clearance < 60 ml/min as calculated by the Cockcroft-Gault formula using the patient's actual weightXx_NEWLINE_xXAdequate renal function defined as calculated creatinine clearance greater than 50 mL/min per the Cockroft and Gault formula.Xx_NEWLINE_xXPatient has adequate renal function (calculated creatinine clearance of ?30 mL/min according to the Cockroft-Gault)Xx_NEWLINE_xXCreatinine clearance > 15 ml/minute using Cockcroft-Gault formulaXx_NEWLINE_xXSerum creatinine =< ULRR or creatinine clearance >= 50 mL/minute (calculated by Cockcroft-Gault formula or measured in a timed urine collection)Xx_NEWLINE_xXCreatinine clearance 45 ml/min or higher calculated using the Cockcroft-Gault formulaXx_NEWLINE_xXSerum 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)Xx_NEWLINE_xXCreatinine clearance (Clcr) < 30 mL/minute as estimated using the Cockroft-Gault formula or on dialysisXx_NEWLINE_xXCreatinine clearance ? 50 mL/min measured by Cockcroft-Gault method.Xx_NEWLINE_xXCreatinine clearance >= 30 mL/min calculated using the Cockcroft-Gault formula (within four weeks prior to the study)Xx_NEWLINE_xXCreatinine clearance of > 50 mL/min per 24 hour urine collection of the Cockcroft-Gault formulaXx_NEWLINE_xXPatients must have adequate renal function as defined by a creatinine clearance >= 40 mL/min (measured or estimated by the Cockcroft-Gault formula)Xx_NEWLINE_xXSerum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearanceXx_NEWLINE_xXCreatinine clearance =< 50 mL/min based either on Cockroft-Gault estimate or based on urine collection (12 or 24 hour)Xx_NEWLINE_xXCreatinine =< 1.5 mg/dL or creatinine clearance >= 40mL/mon (using Cockcroft-Gault formula)Xx_NEWLINE_xXCalculated (e.g. using Cockcroft-Gault formula) or measured creatinine clearance < 50 ml/minXx_NEWLINE_xXEstimated creatinine clearance of >= 30 mL/min, calculated using the formula of Cockcroft and GaultXx_NEWLINE_xXCalculated creatinine clearance >= 50 ml/min by Cockcroft-Gault formula using actual body weightXx_NEWLINE_xXCreatinine =< 2.0 x ULN OR estimated creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault formulaXx_NEWLINE_xXCalculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault formulaXx_NEWLINE_xXCreatinine =< 1.5 mg/dL, or calculated creatinine clearance (determined as per Cockcroft-Gault) >= 50 mL/minXx_NEWLINE_xXCalculated (calc.) creatinine clearance >= 60 mL/min calculated using the Cockcroft-Gault formulaXx_NEWLINE_xXHave 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.Xx_NEWLINE_xXSerum creatinine ? 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) ? 40 mL/min (measured using the Cockcroft-Gault formula)Xx_NEWLINE_xXCalculated creatinine clearance > 40 ml/min using Cockcroft-Gault methodXx_NEWLINE_xXAdequate renal function as evidenced by calculated creatinine clearance ?30 milliliters (mL)/minute according to the Cockcroft and Gault formulaXx_NEWLINE_xXCreatinine clearance >= 50 mL/min/1.73 m^2 (Cockcroft-Gault formula)Xx_NEWLINE_xXThe estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m^2 as calculated by the Cockcroft-Gault formulaXx_NEWLINE_xXActual creatinine clearance of < 60 utilizing the Cockroft-Gault formulaXx_NEWLINE_xXObtained =< 30 days prior to randomization: Calculated creatinine clearance must be >= 30 ml/min using the Cockcroft-Gault formulaXx_NEWLINE_xXCalculated creatinine clearance >= 30 ml/min by Cockcroft-Gault formulaXx_NEWLINE_xXEstimated (Cockroft-Gault formula) or measured creatinine clearance <40 mL/min Brain malignancy or metastases to the brainXx_NEWLINE_xXCreatinine within normal institutional limits OR creatinine clearance >= 60 mL/min using the modified Cockcroft-Gault formulaXx_NEWLINE_xXSerum creatinine > 1.5 x ULRR or creatinine clearance < 30 mL/minute (calculated by Cockcroft-Gault formula)Xx_NEWLINE_xXCalculated creatinine clearance must be >= 30 ml/min using the Cockcroft-Gault formula obtained =< 30 days prior to registrationXx_NEWLINE_xXEstimated creatinine clearance >= 30 mL/min via Cockroft-Gault formulaXx_NEWLINE_xXCalculated creatinine clearance > 40 cc/min by the modified Cockcroft-Gault formulaXx_NEWLINE_xXCalculated creatinine clearance >= 30 mL/min (based on the Cockcroft and Gault method)Xx_NEWLINE_xXPatients with calculated creatinine clearance (Cockroft-Gault) less than 35 mL/minXx_NEWLINE_xXCreatinine =< 2.0 x IULN OR estimated creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault formulaXx_NEWLINE_xXSerum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/minXx_NEWLINE_xXCalculated creatinine clearance > 30 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearanceXx_NEWLINE_xXObtained 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)Xx_NEWLINE_xXAdequate renal function as defined by calculated creatinine clearance =< 40 mL/min (Cockcroft-Gault formula)Xx_NEWLINE_xXCreatinine clearance =< 30 mL/minute (calculated by Cockcroft-Gault formula)Xx_NEWLINE_xXEstimated creatinine clearance greater than 50 mL/minute (using the Cockcroft-Gault formula and actual body weight)Xx_NEWLINE_xXEstimated creatinine clearance greater than 50 mL/minute (using the Cockcroft-Gault formula and actual body weight)Xx_NEWLINE_xXCalculated creatinine clearance >= 60 mL/min (Cockcroft-Gault formula)Xx_NEWLINE_xXParticipants 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 formulaXx_NEWLINE_xXCreatinine =< 1.5 mg/dl OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 ml/min OR 24-hour urine creatinine clearance >= 50 ml/minXx_NEWLINE_xXCreatinine =< 1.5 times the upper limit of normal with creatinine clearance >= 50 mL/min using the modified Cockcroft-Gault methodXx_NEWLINE_xXSerum 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 registrationXx_NEWLINE_xXSerum creatinine ?1.5 mg/dL, and creatinine clearance ? 50 ml/min as measured by Cockcroft and Gault formulaXx_NEWLINE_xXCalculated creatinine clearance >= 30 mL/min using the Calvert FormulaXx_NEWLINE_xXEstimated creatinine clearance (CrCl) >= 30 mL/min according to the Cockcroft-Gault formula or local institutional standard methodXx_NEWLINE_xXCalculated/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 registrationXx_NEWLINE_xXPemetrexed/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 CrClXx_NEWLINE_xXSerum creatinine ? 1.7 mg/dL or calculated creatinine clearance ? 50 mL/min per the Cockcroft and Gault formulaXx_NEWLINE_xXAdequate renal function defined as serum creatinine <1.5×ULN (or calculated creatinine clearance ?50 mL/min per the Cockcroft and Gault formula).Xx_NEWLINE_xXEstimated creatinine clearance >= 30 mL/min according to the Cockcroft-Gault formulaXx_NEWLINE_xXCalculated creatinine clearance (CrCl) ? 50 ml/minute (using Cockcroft and Gault's formula; see APPENDIX 2).Xx_NEWLINE_xXSerum creatinine =< 1.5 x ULN OR creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula)Xx_NEWLINE_xXCreatinine < 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.Xx_NEWLINE_xXCreatinine clearance ?40 mL/min based on Cockcroft-Gault estimate or based on a 12- or 24-hour urine collection.Xx_NEWLINE_xXAdequate 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 formulaXx_NEWLINE_xXAdequate renal function defined as calculated creatinine clearance ?30 mL/min per the Cockcroft and Gault formula.Xx_NEWLINE_xXserum creatinine ?1.5 X institutional UNL or estimated (Cockcroft-Gault formula) or measured creatinine clearance ? 50 mL/minXx_NEWLINE_xXSerum 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 enrollmentXx_NEWLINE_xX