Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00003105


Primary Contact:

Study Chair
Dean F. Bajorin, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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