Combination Chemotherapy in Treating Patients With Advanced Bladder or Kidney Cancer

Memorial Sloan Kettering Cancer Center30 enrolled

Overview

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects of giving gemcitabine, doxorubicin, and paclitaxel together with carboplatin in treating patients with advanced bladder or kidney cancer and impaired kidney function.

OBJECTIVES: * Determine the safety and toxicity of dose-dense carboplatin plus paclitaxel on a weekly schedule given in sequence after gemcitabine and doxorubicin in patients with renal impairment and metastatic or locally advanced transitional cell carcinoma of the urothelium. * Observe the outcome of this sequential systemic chemotherapy in these patients, or following surgical resection as adjuvant therapy in patients in whom poor renal function precludes the use of cisplatin-based chemotherapy. OUTLINE: This is a dose escalation study of carboplatin. Patients receive gemcitabine IV over 10 minutes and doxorubicin IV over 15 minutes for 5 doses on weeks 1, 3, 5, 7, and 9. Filgrastim (G-CSF) is given subcutaneously on days 3 through 10 of each 2-week course. On week 11, patients receive paclitaxel and carboplatin IV over 1 hour weekly for 12 weeks. Each cohort of 3 patients is entered on sequentially increasing doses of carboplatin. If any patient experiences dose limiting toxicity (DLT), then 6 patients are entered at that dose level. If 3 patients experience DLT at any dose level, the maximum tolerated dose has been surpassed and a total of 6 patients are treated at the previous level. Patients are evaluated at week 16 and at end of study. PROJECTED ACCRUAL: There will be 18-30 patients accrued into this study over 9-15 months.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter

Interventions

filgrastimBIOLOGICAL

carboplatinDRUG

doxorubicin hydrochlorideDRUG

gemcitabine hydrochlorideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

New York Weill Cornell Cancer Center at Cornell University

New York, New York, United States

Data from ClinicalTrials.gov

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