Patients with gastrointestinal bleeding or any other hemorrhage/bleeding event Common Terminology Criteria for Adverse Events (CTCAE) grade >= 3 within 30 days prior to study entry
Has known gastrointestinal bleeding or any other hemorrhage/bleeding event Common Terminology Criteria for Adverse Events (CTCAE) grade > 3 within 6 months of start of study drug
Any hemorrhage or bleeding event >= National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade 3 within 4 weeks prior to start of study medication
Has gastrointestinal bleeding or any other hemorrhage/bleeding event Common Terminology Criteria for Adverse Events (CTCAE) grade > 3 within 6 months of registration
Contraindication to antiangiogenic agents, including:\r\n* Serious non-healing wound, non-healing ulcer, or bone fracture\r\n* Major surgical procedure or significant traumatic injury within 4 weeks prior to initiating study treatment\r\n* Pulmonary hemorrhage/bleeding event >= grade 2 (Common Terminology Criteria for Adverse Events [CTCAE] v4.0) within 12 weeks prior to initiating study treatment\r\n* Any other hemorrhage/bleeding event >= grade 3 (CTCAE v4.0) within 12 weeks prior to initiating study treatment
Pulmonary hemorrhage/bleeding event > Common Terminology Criteria for Adverse Events (CTCAE) grade 2 within 4 weeks of first dose of study drug
Contraindication to antiangiogenic agents, including:\r\n* Bronchopulmonary hemorrhage/bleeding event >= grade 2 (Common Terminology Criteria for Adverse Events [CTCAE] v4.0) within 12 weeks prior to of initiation of treatment\r\n* Any other hemorrhage/bleeding event >= grade 3 (CTCAE v4.0) within 12 weeks prior to initiation of treatment\r\n* Serious non-healing wound, ulcer, or bone fracture
Patients with gastrointestinal bleeding or any other hemorrhage/bleeding event (Common Terminology Criteria for Adverse Events [CTCAE] version [v.]4) grade 3 or greater within 30 days prior to registration will be ineligible
Contraindication to antiangiogenic agents, including:\r\n* Bronchopulmonary hemorrhage/bleeding event >= grade 2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4.0) within 4 weeks or less prior to first dose of study drug\r\n* Any other hemorrhage/bleeding event >= grade 3 (CTCAE version [v]4.0) within 4 weeks or less prior to first dose of study treatment\r\n* Radiological evidence of any intracranial hemorrhage within the 4 weeks or less prior to first dose of study treatment \r\n* History of significant intratumoral, intracerebral, or subarachnoid hemorrhage\r\n* Serious non-healing wound, ulcer, or bone fracture\r\n* Documented bowel perforation within 6 months of the start of study treatment
Pulmonary hemorrhage/bleeding event >= Common Terminology Criteria for Adverse Events (CTCAE) grade 2 within 4 weeks of first dose of study drug
Subjects who have a history or current evidence of bleeding disorder, i.e. any hemorrhage/bleeding event of Common Terminology Criteria for Adverse Events (CTCAE) grade >= 2 within 4 weeks before the start of study treatment
Has history of gastrointestinal bleeding or any other hemorrhage/bleeding event >= grade 3 (Common Terminology Criteria for Adverse Events [CTCAE], version [v.] 4) within 30 days prior to entry in to the trial
Subjects who have a history or current evidence of bleeding disorder, i.e. any hemorrhage / bleeding event of CTCAE (Common Terminology Criteria for Adverse Events) Grade ?2 within 4 weeks before the start of study Treatment.
Has gastrointestinal bleeding or any other hemorrhage/bleeding event Common Terminology Criteria for Adverse Events (CTCAE) grade > 3 within 6 months of start of study drug
Any hemorrhage or bleeding event >= National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4 grade 3 =< 4 weeks prior to registration
Gastrointestinal bleeding or any other hemorrhage/bleeding event Common Terminology Criteria for adverse Events (CTCAE), v. 4 grade 3 or greater within 30 days prior to registration
Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event ? CTCAE Grade 3 within 4 weeks of start of study medication (CTCAE: Common Terminology Criteria for Adverse Events).
Patients with gastrointestinal bleeding or any other hemorrhage/bleeding event Common Terminology Criteria for Adverse Events (CTCAE) grade >= 3 within 30 days prior to study entry
Evidence or history of bleeding diathesis. Any hemorrhage/bleeding event ? CTCAE (Common terminology criteria for adverse events) Grade 3 within 4 weeks of first dose of study drug
Any hemorrhage or bleeding event >= National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 grade 3 within 4 weeks prior to start of study medication
Has gastrointestinal bleeding or any other hemorrhage/bleeding event National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) >Grade 3 within 6 months of start of study drug.
Pulmonary hemorrhage/bleeding event > National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 4.0) grade 2 within 4 weeks of enrollment
Pulmonary hemorrhage/bleeding event >= Common Terminology Criteria for Adverse Events (CTCAE) grade 2 within 4 weeks of first dose of study drug
Pulmonary hemorrhage/bleeding event >= Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 within 4 weeks of first dose of study drug
Any hemorrhage or bleeding event >= Common Terminology Criteria for Adverse Events (CTCAE) grade 3 within 4 weeks prior to start of study medication
Patients must have completed prior chemotherapy, immunotherapy, or radiation therapy at least 14 days prior to step 2 randomization and all toxicity must be resolved to Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 grade 1 (with the exception of CTCAE v4.0 grade 2 neuropathy) prior to step 2 randomization
Recovered from adverse events to grade 1 or less toxicity according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE 4.0) due to agents administered previously\r\n* NOTE: Chemotherapy-induced alopecia and grade 2 neuropathy are acceptable
Patient has Common Toxicity Criteria for Adverse Effects (CTCAE) v 4.0 grade ? 2 hemorrhage
Presence of grade >= 2 Common Terminology Criteria for Adverse Events (CTCAE) toxicity (CTCAE grade 2 peripheral neuropathy and ototoxicity and any grade alopecia are allowed)
Recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or less toxicity from other agents with exception of alopecia and fatigue
Thyroid function abnormality ? Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2.
Failure to recover (to Common Terminology Criteria for Adverse Events [CTCAE Version 4.0] Grade 0 or Grade 1) from acute non-hematologic toxicity (except alopecia or Grade 2 or lower neuropathy), due to previous therapy, prior to Screening.
Participants who have not recovered to =< Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or baseline from toxicity as a result of previous cancer treatment prior to entering the study (with the exception of alopecia and peripheral neuropathy which can be =< grade 2)
Recovered from adverse events (to grade 1 or less toxicity according to Common Terminology Criteria for Adverse Events [CTCAE] 4.0) due to agents administered previously; NOTE: chemotherapy-induced alopecia and grade 2 neuropathy are acceptable
Patients must be recovered from any toxicity related to prior anti-neoplastic therapy (to grade < 1); patients with Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or less sensory neuropathy or any grade alopecia are eligible
For subjects with muscle invasive disease: not suitable neoadjuvant cisplatin­based chemotherapy as determined by the following:\r\n* Creatinine clearance less than 60 ml/min\r\n* Common Terminology Criteria for Adverse Events (CTCAE) grade (gr) >= 2 hearing loss\r\n* CTCAE gr >= 2 neuropathy
Lack of recovery of prior adverse events due to prior cancer therapy to grade =< 1 (NCI Common Terminology Criteria for Adverse Events [CTCAE]; except alopecia); electrolyte abnormalities that are corrected with supplementation will be eligible; patients with platinum-related grade 2 or greater hypomagnesemia (on replacement) will be eligible; stable persistent grade 2 peripheral neuropathy may be allowed as determined on a case-by-case basis at the discretion of the principal investigator (PI)
Persistent prior therapy-related toxicities greater than grade 2 according to Common Toxicity Criteria for Adverse Events (CTCAE) v4.03, except for peripheral neuropathy, alopecia, or vitiligo prior to enrollment.
Subjects must have progressed despite at least 1 prior line of treatment for metastatic and/or unresectable urothelial cancer. However, cisplatin-ineligible (defined by a calculated creatinine clearance of >= 40 but < 60 mL/min OR Common Terminology Criteria for Adverse Events [CTCAE] version [v]4 grade >= 2 audiometric hearing loss OR CTCAE v4 grade >= 2 peripheral neuropathy OR ECOG performance status [PS] = 2), chemotherapy-naive subjects are also eligible
Presence of ? Common Terminology Criteria for Adverse Events (CTCAE) grade 2 toxicity due to prior cancer therapy (except alopecia, peripheral neuropathy which are excluded if ? CTCAE grade 3)
Ineligible to receive cisplatin by meeting one or more of the following criteria\r\n* Creatinine clearance of < 50 mL/min\r\n* Hearing loss of 25 dB at two contiguous frequencies\r\n* Common Terminology Criteria for Adverse Events (CTCAE) version 4 (v4) grade 2 or higher peripheral neuropathy\r\n* New York Heart Association class III or IV heart failure\r\n* ECOG performance status 2 or higher
Subjects with >= Common Terminology Criteria for Adverse Events (CTCAE) grade 2 toxicity (except alopecia) due to prior cancer therapy.
Must have completed prior chemotherapy, immunotherapy, or radiation therapy at least 14 days prior to start of treatment and all toxicity must be resolved to Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grade 1 (with the exception of CTCAE v4.0 grade 2 neuropathy) prior to start of treatment
Patients must have recovered from toxicity related to prior therapy to at least grade 1 (defined by CTCAE 4.0) or baseline level. Chronic stable grade 2 peripheral neuropathy secondary to neurotoxicity from prior therapies may be considered on a case by case basis by the Principal Investigator.
Unresolved toxicity from previous anticancer treatments, including investigational products (subjects must have recovered all unacceptable toxicity to ? Grade 1 Common Terminology Criteria for Adverse Events [CTCAE] toxicity). This does not extend to symptoms or findings that are attributable to the underlying disease
Presence of >= Common Terminology Criteria for Adverse Events (CTCAE) grade 2 toxicity (except alopecia or peripheral neuropathy) due to prior cancer therapy
Patients must have recovered from toxicity related to prior therapy to at least grade 1 (defined by Common Terminology Criteria for Adverse Events version 4.0 [CTCAE 4.0]) or baseline level; chronic stable grade 2 peripheral neuropathy secondary to neurotoxicity from prior therapies may be considered on a case by case basis by the principal investigator
Must have recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or better from the acute effects of any prior surgery, chemotherapy or radiation therapy; chronic residual toxicity (i.e. peripheral neuropathy) is permitted
Toxicities from prior therapies, with the exception of peripheral neuropathy attributable to bortezomib, must have recovered to grade =< 2 according to the Common Toxicity Criteria (CTC) 4.0 criteria or to the subject’s prior baseline
Patients eligible or ineligible for cisplatin-based chemotherapy. Cisplatin ineligibility is defined as meeting 1 of the following criteria: • Creatinine clearance (calculated or measured) <60 mL/min calculated by Cockcroft-Gault equation (using actual body weight) or by measured 24-hour urine collection for determination • Common Terminology Criteria for Adverse Events (CTCAE) Grade ?2 audiometric hearing loss • CTCAE Grade ?2 peripheral neuropathy • New York Heart Association ?Class III heart failure.
Have received anti-cancer therapies listed below within the specified timeframe, or who have ongoing toxicity from prior therapy > Grade 1 according to the Common Terminology for Adverse Events (CTCAE). Exceptions to this are: > Grade 1 toxicities which in the opinion of the Investigator should not exclude the subject (e.g. alopecia, Grade 2 neuropathy, hypo- or hyperthyroidism or other endocrinopathies that are well-controlled with hormone replacement) and are approved by the Medical Monitor.
Other organ toxicity due to prior anticancer therapy (investigational agent, chemotherapy, or radiation therapy) except alopecia, and ototoxicity due to cisplatin not already covered in the inclusion/exclusion criteria, which has not recovered to Grade less than 2 per Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Documented hypercoagulable disorders or vasculopathies:\r\n* International normalized ratio (INR) value more than a grade 1 toxicity by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0 criteria (> 1-1.5 x upper limit of normal [ULN]; > 1-1.5 times above baseline if on anticoagulation)\r\n* Activated partial thromboplastin time (APTT) value more than a grade 1 toxicity by CTCAE v 4.0 criteria (> ULN-1.5 x ULN)
Prior systemic or antiangiogenic therapy for HCC (including thalidomide, sorafenib, sunitinib, or bevacizumab); prior systemic therapy for other diagnoses is permitted if greater than 6 months have elapsed since last dose, any prior toxicity has recovered to =< grade 1 by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0, and treatment was not discontinued for toxicity
Toxicities from previous cancer therapies must have recovered to grade 1 (defined by Common Terminology Criteria for Adverse Events [CTCAE] 4.0) Chronic stable grade 2 peripheral neuropathy secondary to neurotoxicity from prior therapies may be considered on a case by case basis
Not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia, oxaliplatin-related neuropathy, asymptomatic electrolyte abnormalities =< grade 2, and other non-clinically significant adverse events
Failure to recover (to Common Terminology Criteria for Adverse Events [CTCAE] Grade 0 or Grade 1) from acute non hematologic toxicity (except all grades alopecia or Grade 2 or lower neuropathy ), due to previous therapy, prior to Screening.
Previous chemotherapy, immunotherapy, or radiation therapy must have been completed at least 14 days prior to Step 2 Randomization and all toxicity must be resolved to Common Toxicity Criteria for Adverse Events (CTCAE) version (v) 4.0 grade 1 (with the exception of CTCAE v4.0 grade 2 neuropathy) prior to Step 2 Randomization
Not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia and neuropathy; alopecia and neuropathy must have resolved to =< grade 2; congestive heart failure (CHF) must have been =< grade 1 in severity at the time of occurrence and must have resolved completely prior to registration
Persistent Common Toxicity Criteria for Adverse Effects (CTCAE v4.0) greater than or equal to grade 2 diarrhea regardless of etiology.
Presence of any unresolved >=Grade 2 (per Common Terminology Criteria for Adverse Events [CTCAE] version 4.0) toxicity from previous anti-cancer therapy at the time of enrollment, except alopecia or Grade 2 anemia. Subjects with MM who have ?Grade 2 peripheral neuropathy (per CTCAE v4.0) are permitted.
Clinically significant peripheral neuropathy (defined as >= Common Terminology Criteria for Adverse Events [CTCAE] grade 2 [version 4.0]), neurosensory or neuromotor toxicity, regardless of causality
Subjects must be recovered from any toxicity related to prior anti?neoplastic therapy (to grade =< 1); patients with Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or less sensory neuropathy or any grade alopecia are eligible
Any persistent, unresolved Common Terminology Criteria for Adverse Events (CTCAE) Grade ?2 drug-related toxicity (except alopecia, erectile impotence, tinnitus, hot flashes, and loss of libido) associated with previous treatment. Inclusion of patients with persistent neuropathy or hearing loss Grade ?2 due to previous treatment requires discussion with the sponsor.
Has not recovered (i.e., equivalent to a Common Terminology Criteria for Adverse Events [CTCAE] ?Grade 2) from the clinically significant toxic effects of prior anticancer therapy. Exception: subjects who have received treatment with a proteasome inhibitor such as bortezomib may have CTCAE Grade 2 neuropathy.
Lack of recovery of prior cancer therapy-related adverse events to grade =< 1 (NCI Common Terminology Criteria for Adverse Events [CTCAE] v4.03; except alopecia); stable persistent grade 2 peripheral neuropathy may be allowed as determined on a case-by-case basis at the discretion of the principal investigator (PI); patients with platinum-related grade 2 or greater hypomagnesemia (on replacement) will be eligible
Patients who have not recovered (Common Terminology Criteria for Adverse Events [CTCAE] =< grade 1) from adverse events due to prior treatments, except for alopecia, or base stable grade 2 tinnitus (not interfering with activities of daily living [ADL]’s) or stable grade 2 sensory neuropathy without pain or motor component, and not interfering with ADL’s
Patients must have completed surgical resection and adjuvant chemotherapy (adjuvant radiotherapy excluded) with no significant persisting treatment related toxicity (grade 1 toxicity per Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.0 allowed) as determined by the treating physician
Recovery from acute toxicity of prior treatment for renal cell carcinoma (RCC) (to =< grade 1 the active version of Common Terminology Criteria for Adverse Events [CTCAE] or to a level permitted under other sections of inclusion/ exclusion criteria); additionally, in patients who have received standard or experimental treatments for their RCC at least approximately 5 half-lives should have elapsed from the last dose at the time of study entry
Subject who has an ongoing toxicity ? Grade 2 (Common Terminology Criteria for Adverse Event [CTCAE] v4.03) attributable to prior medication to treat solid tumor (except alopecia) at the time of screening.
Patients may not have any baseline comorbidities or laboratory abnormalities which would be of grade 3 or worse if graded as toxicities by Common Terminology Criteria for Adverse Events (CTCAE) (excepting alopecia); an exception is also made for neurologic comorbidities (e.g. ataxia, aphasia) arising as a consequence of the brain tumor; symptoms severe enough to warrant medical treatment as is offered on this study are by definition grade 3
Recovery to CTCAE (Common Terminology Criteria for Adverse Events Version 4.03) Grade 0 or Grade 1 or recovery to baseline preceding the prior treatment of any previous drug / procedure-related toxicity (except alopecia, anemia, and hypothyroidism)
Must have recovered from any acute toxicity related to prior therapy, including surgery; toxicity should be =< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version 4 or has returned to baseline; alopecia > grade 1 is permitted
Patients who have not recovered (Common Toxicity Criteria [CTC] =< grade I) from adverse events due to prior treatments
Subject has an ongoing toxicity ? Grade 2 (Common Terminology Criteria for Adverse Event [CTCAE] v4.03) attributable to prior medication to treat solid tumor (except alopecia) at the time of screening.
Presence of >= Common Terminology Criteria for Adverse Events (CTCAE) grade 2 toxicity (except alopecia) due to prior therapy
Presence of >= grade 3 non-hematologic toxicity common terminology criteria (CTC) version 4 from the previous treatment
Recovered from adverse events (to grade 1 or less toxicity according to Common Terminology Criteria for Adverse Events [CTCAE] 4.0) due to agents administered previously; NOTE: chemotherapy-induced alopecia and grade 2 neuropathy are acceptable
Nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) >= grade 2, per the Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0
STEP I: Patients must not have grade 2 or higher peripheral neuropathy by Common Terminology Criteria for Adverse Events (CTCAE) 4.0
Symptomatic peripheral sensory neuropathy >= grade 2 (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.0) in patients with no prior oxaliplatin therapy
Patients must not have Common Terminology Criteria for Adverse Events (CTCAE) >= grade 2 neuropathy (cranial, motor or sensory) within 14 days prior to registration
Symptomatic peripheral neuropathy >= grade 2 Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0 (for participants receiving docetaxel only)
Peripheral sensory neuropathy >/= Common Terminology Criteria for Adverse Events (CTCAE) Grade 2
Pre-existing, clinically significant peripheral neuropathy, defined as Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher neurosensory or neuromotor toxicity, regardless of etiology
Neurologic function: neuropathy (sensory and motor) less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) grade 1
Patients must have < grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE])
Has pre-existing peripheral neuropathy that is ? Grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) version 4 criteria.
Subjects must have < grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE])
STUDY TREATMENT: Peripheral neuropathy less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) grade 1.
Patients with peripheral neuropathy > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Neuropathy (sensory and motor) less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) grade 1
No Common Terminology Criteria for Adverse Events (CTCAE) v4 grade > 2 neuropathy
Nervous system disorder (i.e., paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) >= grade 2, per Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0
Peripheral neuropathy ? grade 2 (Common Terminology Criteria for Adverse Events CTCAE)
Pre-existing peripheral neuropathy > grade 1 (using Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4.3 criteria)
Neuropathy (sensory and motor) =< Common Terminology Criteria for Adverse Events (CTCAE) grade 1
Must have =< grade 1 pre-existing peripheral neuropathy (as per Common Terminology Criteria for Adverse Events [CTCAE])
Pre-existing motor or sensory neurotoxicity greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1
Patients must have < grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE])
Grade 3 or worse peripheral neuropathy as defined by Common Terminology Criteria for Adverse Events (CTCAE) v4.1
Peripheral neuropathy =< Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Neuropathy (sensory and motor) less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (v4.0) grade 1 acceptable
Patients must have < grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE])
Pre-existing peripheral neuropathy that is >= grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 criteria
Nervous system disorder (paresthesias, peripheral motor neuropathy, or peripheral sensory neuropathy) >= grade 2, per the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Patients must have < grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE])
Patients must have < grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE])
Patients with =< grade 1 peripheral neuropathy are eligible for this trial using the Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0, regardless of use of therapy for neuropathy including gabapentin
Presence of CTCAE (Common Terminology Criteria for Adverse Events) grade ? 2 peripheral neuropathy.
Peripheral neuropathy of Common Terminology Criteria for Adverse Events (CTCAE) v4.03 grade >= 2
Nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) >= grade 2, per the Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0
Peripheral neuropathy of grade 2 or greater by Common Terminology Criteria for Adverse Events (CTCAE) 4.0. In CTCAE version 4.0 grade 2 sensory neuropathy is defined as “moderate symptoms; limiting instrumental activities of daily living (ADLs).
Pre-existing peripheral neuropathy that is >= grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) v4 criteria
Sensory peripheral neuropathy > Common Terminology Criteria for Adverse Events (CTCAE) grade 1
Patients with peripheral neuropathy >= Common Terminology Criteria for Adverse Events (CTCAE) grade 2 are ineligible
Sensory peripheral neuropathy =< grade 1 (per Common Terminology Criteria for Adverse Events [CTCAE] version [v.] 4.0)
Patients with pre-treatment peripheral neuropathy greater than grade 1 per the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 will be excluded
Symptomatic peripheral neuropathy > grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) criteria
Nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) >= grade 2, per the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Pre-existing peripheral neuropathy, if present, must be < grade 2 (per Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)
Preexisting peripheral neuropathy of Grade 2, 3, or 4 (per Common Terminology Criteria for Adverse Events v4.0).
For Cohort B: Has peripheral neuropathy Common Terminology Criteria for Adverse Events ?2 except due to trauma
Peripheral neuropathy >= grade 2 (per Common Terminology Criteria for Adverse Events [CTCAE] version [v]4)
Neuropathy (sensory and motor) less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) grade 1
Presence of peripheral neuropathy ? Common Terminology Criteria for Adverse Events (CTCAE) Grade 2
Patients must have < grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE])
Peripheral neuropathy Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher
Peripheral neuropathy of grade 2 or greater by Common Terminology Criteria for Adverse Events (CTCAE) 4.0; in CTCAE version 4.0 grade 2 sensory neuropathy is defined as \moderate symptoms; limiting instrumental activities of daily living (ADLs)\
Neuropathy (sensory) =< Common Terminology Criteria for Adverse Events (CTCAE) grade 1
Patients with peripheral neuropathy > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
Patients must have < grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE])
Patients with =< grade 1 peripheral neuropathy are eligible for this trial using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0, regardless of use of therapy for neuropathy including gabapentin
Patients must not have >= grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE])
< grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE])
Presence of peripheral neuropathy ? Common Terminology Criteria for Adverse Events (CTCAE) Grade 2
Patients with pre-existing neuropathy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 (motor or sensory)
Patients must have < grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE])
Preexisting peripheral neuropathy of grade 2, 3, or 4 (per Common Terminology Criteria for Adverse Events v 4.0)
Patients must not have grade 2 or greater pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE] 4.0)
Pre-existing peripheral neuropathy of Grade 2, 3, or 4 (per Criteria for Adverse Events (CTCAE) v4.0).
Patients must have < grade 2 pre-existing peripheral neuropathy per Common Terminology Criteria for Adverse Events (CTCAE)
Peripheral neuropathy of grade 2 or greater by Common Terminology Criteria for Adverse Events (CTCAE) 4.0; in CTCAE version 4.0 grade 2 sensory neuropathy is defined as \moderate symptoms; limiting instrumental activities of daily living (ADLs)\
Current peripheral neuropathy greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 except due to trauma
Patients must have =< grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE] v4.0)
Patients with pre-existing peripheral neuropathy must have < grade 2 (per Common Terminology Criteria for Adverse Events [CTCAE] 4.0) at the time of registration
Patients must have < grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events 4.03 [CTCAE 4.03])