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

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with progressive metastatic transitional cell cancer of the urothelium.

OBJECTIVES:

Primary

* Determine the response rate in patients with progressive metastatic transitional cell carcinoma of the urothelium treated with sunitinib malate.
* Determine the safety of this regimen in these patients.

Secondary

* Determine the time to disease progression in patients treated with this regimen.

  * To determine time to tumor progression (TTP) for sunitinib malate on a continuous dosing schedule for treatment of metastatic urothelial carcinoma.
  * To estimate sunitinib and SU012662 trough plasma concentration (Ctrough) data for the continuous daily schedule and to determine potential association with efficacy and safety.

Eligibility Criteria:
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)