Clinical Drug Experience Knowledgebase

Criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

Diagnosis of papillary renal cell carcinoma

Locally advanced or metastatic disease
Type I or type II disease
Progressive disease
Measurable disease defined by RECIST criteria as at least 1 lesion at least 2 cm in length by conventional CT scan techniques or at least 1 cm by spiral CT scan
No brain metastases including treated and nonprogressive metastases

PATIENT CHARACTERISTICS:

Inclusion criteria:

ECOG performance status 0-1
Life expectancy ≥ 3 months
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 8 g/dL
Total bilirubin ≤ 3 mg/dL
AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
Serum creatinine < 1.5 times ULN
INR ≤ 1.7 or PT ≤ 6 seconds over ULN
Not pregnant or nursing
Fertile patients must use effective contraception
Patients must be affiliated to a Social Security System
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

Exclusion criteria:

NCI CTC grade 3 hemorrhage within 4 weeks prior to start of study treatment
Diagnosis of any second malignancy within the past 3 years except for basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix that has been adequately treated with no evidence of recurrent disease within the past 12 months
Spinal cord compression, carcinomatous meningitis, or leptomeningeal disease

Any of the following within the past 12 months prior to study drug administration:

Severe/unstable angina
Myocardial infarction
Coronary artery bypass graft
Symptomatic congestive heart failure
Cerebrovascular accident including transient ischemic attack
Pulmonary embolism

Any of the following conditions:

Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2
Atrial fibrillation of any grade
Prolongation of the QTc interval to > 450 msec for males or > 470 msec for females
Hypertension that cannot be controlled by medications
Inability to swallow oral medications or presence of active inflammatory bowel disease, partial or complete bowel obstruction, or chronic diarrhea
Known HIV or AIDS infection
Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration
Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and the follow-up schedule
Patients deprived of liberty or placed under the authority of a tutor

PRIOR CONCURRENT THERAPY:

Recovered from all toxic effects of any prior local treatment to CTCAE version 3.0 grade ≤ 1

At least 4 weeks since prior radiotherapy

At least 1 week since prior radiotherapy to < 10% of the whole body allowed provided side effects are < grade 2 and there is at least one site for evaluation

More than 2 weeks since prior and no concurrent anticoagulant agents or therapeutic doses of warfarin

Low-dose warfarin (up to 2 mg/day) for deep vein thrombosis prophylaxis allowed
Low molecular weight heparin allowed
No prior specific medical systemic therapy (i.e., first-line therapy)
No prior sunitinib malate
No prior investigational agents
No concurrent treatment on another therapeutic clinical trial