Sunitinib in Treating Patients With Progressive Metastatic Transitional Cell Cancer of the Urothe… (NCT00397488) | Clinical Trial Compass
CompletedPhase 2
Sunitinib in Treating Patients With Progressive Metastatic Transitional Cell Cancer of the Urothelium
United States78 participantsStarted 2006-09
Plain-language 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.
Who can participate
Age range18 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 infarc…