Combination Chemotherapy in Treating Patients With Advanced Bladder or Kidney Cancer
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring stage III bladder cancer, stage IV bladder cancer, transitional cell carcinoma of the bladder, metastatic transitional cell cancer of the renal pelvis and ureter, localized transitional cell cancer of the renal pelvis and ureter, regional transitional cell cancer of the renal pelvis and ureter
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed advanced transitional cell urothelial cancer Clinical Stage IV: T any, N1-3, M0; T any, N any, M1; or cT4, Nx, M0 (bladder tumors) Pathological Stage III or IV bladder cancer: T any, N1-3, M0; T3b, N0, M0; T4, N0, M0; and T4, Nx, M0 Pathological Stage III or IV urothelial cancer of the renal pelvis or ureter: T any, N1-3, M0; T3, N0, M0; T4, N0, M0; and surgery has been performed within 10 weeks of initiation of therapy Impaired renal function (See Renal function tests) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% OR ECOG 0-1 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm^3 Platelet count at least 150,000/mm^3 Hepatic: Bilirubin less than 1.5 times normal Alkaline phosphatase less than 2 times normal SGOT less than 2 times normal Renal: Creatinine greater than 1.5 mg/dL but no greater than 2.5 mg/dL OR Creatinine clearance 30-59 mL/min Cardiovascular: Normal cardiac function by history, physical examination, and chest radiograph OR If prior cardiac disease, left ventricular ejection fraction must be at least 50% by radionuclide ventriculogram or echocardiogram No serious cardiac arrhythmias; including first, second, and third degree heart block No New York Heart Association class III or IV heart disease Other: No uncontrolled infection No other active cancer, except nonmelanomatous skin cancer and in situ carcinoma of the cervix curatively treated Not pregnant Effective barrier contraception required for all fertile patients during and for 6 months after therapy (encouraged to continue for 2 years or longer) PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the bladder At least 4 weeks since any other prior radiotherapy Surgery: See Disease Characteristics
Sites / Locations
- Memorial Sloan-Kettering Cancer Center
- New York Weill Cornell Cancer Center at Cornell University