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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.
Full description
OBJECTIVES:
Primary
Secondary
Determine the time to disease progression in patients treated with this regimen.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed transitional cell carcinoma of the urothelium, including 1 of the following sites:
Progressive metastatic disease
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:
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:
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:
Primary purpose
Allocation
Interventional model
Masking
78 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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