Sunitinib Malate in Treating Patients With Locally Recurrent, Locally Advanced, Unresectable, or … (NCT01118039) | Clinical Trial Compass
UnknownPhase 2
Sunitinib Malate in Treating Patients With Locally Recurrent, Locally Advanced, Unresectable, or Metastatic Urinary Tract Cancer
Spain41 participantsStarted 2006-07
Plain-language summary
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying the side effects of giving sunitinib malate and to see how well it works in treating patients with locally recurrent, locally advanced, unresectable, or metastatic urinary tract cancer.
Who can participate
Age range18 Years
SexALL
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DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed transitional cell carcinoma of the urinary tract meeting ≥ 1 of the following criteria:
* Unresectable, locally recurrent disease
* Locally recurrent disease must not be amenable to resection or radiotherapy with curative intent
* Locally advanced or metastatic disease
* No prior chemotherapy for advanced disease
* Ineligible (unfit) for cisplatin-based chemotherapy due to creatinine clearance \< 60 mL/min but \> 30 mL/min
* Measurable or nonmeasurable disease according to RECIST criteria
* Measurable lesions that have been previously irradiated will not be considered target lesions unless increase in size has been observed following completion of radiation therapy
PATIENT CHARACTERISTICS:
* See Disease Characteristics
* ECOG performance status 0-1
* Life expectancy \> 12 weeks
* Absolute neutrophil count ≥ 1,500/μL
* Platelet count ≥ 100,000/μL
* Hemoglobin ≥ 9.0 g/dL
* Total serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Serum creatinine ≤ 1.5 times ULN
* AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN if liver function abnormalities are due to underlying malignancy)
* Serum albumin ≥ 3.0 g/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during study therapy
* No diagnosis of a second malignancy within the past 3 years except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervi…