Combination Chemotherapy in Patients With Advanced Urinary Tract Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Trial of Paclitaxel, Cisplatin and Ifosfamide in Patients With Advanced Urothelial Tumors

Conditions
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Bladder Cancer, Urethral Cancer

Intervention / Treatment
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* Drug: cisplatin
* Drug: ifosfamide
* Drug: paclitaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: ifosfamide|nan|
|Drug: paclitaxel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III bladder cancer, recurrent bladder cancer, stage IV bladder cancer, squamous cell carcinoma of the bladder, adenocarcinoma of the bladder, recurrent urethral cancer, distal urethral cancer, proximal urethral cancer, urethral cancer associated with invasive bladder cancer