Clinical trial NCT00541008 (phase 2, status: completed)
Conditions: kidney cancer
ICD codes: D17.71, D30.00, D30.01, D30.02, D41.00, D41.01, D41.02
Drugs: sunitinib malate
SMILES: CCN(CC)CCNC(=O)C1=C(C)NC(\C=C2/C(=O)NC3=C2C=C(F)C=C3)=C1C
Eligibility 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