Expired Study
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New York, New York 10021


Purpose:

RATIONALE: Drugs used in chemotherapy, such as cisplatin, ifosfamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells. PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with metastatic urinary tract cancer that cannot be treated with surgery.


Study summary:

OBJECTIVES: - Determine the efficacy of cisplatin, ifosfamide, and paclitaxel in patients with unresectable or metastatic urothelial cancer (nontransitional cell histologies). OUTLINE: Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-3. Filgrastim (G-CSF) is administered subcutaneously daily beginning on day 6 and continuing through day 17 or until blood counts recover. Treatment continues every 3 weeks for a maximum of 6 courses in the absence of stable or progressive disease after completion of course 2 or complete response after completion of course 4. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.


Criteria:

DISEASE CHARACTERISTICS: - Histologically proven unresectable or metastatic urothelial cancer - No transitional cell histologies - Bidimensionally measurable disease PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Hematopoietic: - WBC at least 3,500/mm^3 - Platelet count greater than 150,000/mm^3 Hepatic: - Bilirubin less than 2.0 mg/dL Renal: - Creatinine less than 1.5 mg/dL OR - Creatinine clearance greater than 55 mL/min Cardiovascular: - No New York Heart Association class III or IV heart disease Other: - No other concurrent malignancy except basal cell skin cancer 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 - Not specified


NCT ID:

NCT00002684


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: October 18, 2017

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