Bladder Cancer Clinical Trial
Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Bladder Cancer
Summary
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.
Full Description
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.
Eligibility Criteria
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
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There is 1 Location for this study
New York New York, 10021, United States
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