Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Bladder 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: Phase I/II trial to study the effectiveness of combination chemotherapy in treating patients with metastatic or locally advanced bladder cancer.

OBJECTIVES: * Determine the safety and toxicity of doxorubicin, gemcitabine, and filgrastim (G-CSF) followed by ifosfamide, paclitaxel, cisplatin, and G-CSF in patients with metastatic or locally advanced transitional cell carcinoma of the urothelium. * Determine the efficacy of this regimen in this patient population. OUTLINE: This is a dose-escalation study of gemcitabine. Patients receive doxorubicin IV over 30 minutes and gemcitabine IV on day 1 and filgrastim (G-CSF) subcutaneously (SC) on days 3-11. Treatment repeats every 2 weeks for 5 courses. After completion of the fifth course, patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1, ifosfamide IV over 1 hour on days 1-3, and G-CSF SC daily on days 6-17. Treatment repeats every 3-4 weeks for 4 courses. Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 3 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at the MTD. PROJECTED ACCRUAL: A maximum of 20 patients will be accrued for phase I and a maximum of 10 patients will be accrued for phase II within 2-3 years.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter

Interventions

filgrastimBIOLOGICAL

cisplatinDRUG

doxorubicin hydrochlorideDRUG

gemcitabine hydrochlorideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically confirmed transitional cell carcinoma of the urothelium * Measurable disease, defined as unresectable or metastatic urothelial tract tumors OR * Evaluable disease, defined as T3b or T4a bladder tumors PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% Life expectancy: * Not specified Hematopoietic: * Granulocyte count greater than 1,500/mm\^3 * Platelet count greater than 150,000/mm\^3 Hepatic: * Bilirubin less than 1.5 times normal * SGOT less than 2 times normal Renal: * Creatinine less than 1.5 mg/dL OR * Creatinine clearance greater than 60 mL/min Cardiovascular: * No New York Heart Association class III or IV heart disease * No serious cardiac arrhythmias, including first, second, or third degree heart block * LVEF at least 50% Other: * No uncontrolled infection * No other active malignancy except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix * Fertile patients must use effective barrier contraception before, during, and for 6 months after study and are encouraged to continue for 2 years or longer after study PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior systemic chemotherapy Endocrine therapy: * Not specified Radiotherapy: * At least 3 weeks since prior radiotherapy Surgery: * See Disease Characteristics

Locations (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.