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

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: National Cancer Institute (NCI); Pfizer
• Treatments: Sunitinib

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)