Sunitinib in Treating Patients With Progressive Metastatic Transitional Cell Cancer of the Urothelium

DISEASE CHARACTERISTICS:

• Histologically confirmed transitional cell carcinoma of the urothelium, including 1 of the following sites:

  • Bladder
  • Urethra
  • Ureter
  • Renal pelvis

• Progressive metastatic disease

  • Progressive disease defined as new or progressive lesions on cross-sectional imaging
  • Progressed despite prior treatment with cytotoxic chemotherapy
• Measurable disease

• Previously treated disease, as defined by the following:

  • Received treatment with 1-4 cytotoxic agents

  • Prior therapy must have included ≥ 1 of the following:

    • Cisplatin
    • Carboplatin
    • Paclitaxel
    • Docetaxel
    • Gemcitabine hydrochloride
  • Prior cytotoxic agents in the perioperative or metastatic setting allowed and may have been administered sequentially (e.g., first-line treatment followed by second-line treatment at time of progression) or all as part of a single regimen
• No symptomatic CNS metastases

PATIENT CHARACTERISTICS:

• Karnofsky performance status 60-100%
• Absolute neutrophil count ≥ 1,000/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 8.0 g/dL
• Bilirubin ≤ 1.5 mg/dL (unless Gilbert's disease is present)
• AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver function abnormalities are due to underlying malignancy)
• Creatinine ≤ 2.0 mg/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

• None of the following within the past 6 months:

  • Myocardial infarction
  • Severe or unstable angina
  • Coronary or peripheral artery bypass graft
  • Symptomatic congestive heart failure
  • Cerebrovascular accident or transient ischemic attack
  • Pulmonary embolism
• No ongoing cardiac dysrhythmias ≥ grade 2
• No prolonged QTc interval on baseline ECG
• No uncontrolled hypertension, defined as blood pressure > 150/100 mm Hg despite optimal medical therapy
• No preexisting thyroid abnormality (i.e., thyroid function tests that cannot be maintained in the normal range with medication)
• No known HIV- or AIDS-related illness or other active infection

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy or chemotherapy
• At least 4 weeks since prior major surgery
• No other concurrent investigational drugs
• No concurrent participation in another clinical trial (supportive care trials or non-treatment trials [e.g., quality of life] allowed)
• No concurrent therapeutic doses of warfarin (low-dose warfarin ≤ 2 mg once daily for thromboembolic prophylaxis allowed)