Combination Chemotherapy Following Surgery in Treating Patients With Urinary Tract Cancer

Study Overview
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Brief Summary
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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 II trial to study the effectiveness of combination chemotherapy following surgery in treating patients who have urinary tract cancer.

Detailed Description
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OBJECTIVES: Determine the time to treatment failure and disease-free survival in patients with high-risk transitional cell carcinoma of the urothelium treated with adjuvant paclitaxel, ifosfamide, carboplatin, and gemcitabine. Determine the tolerability and feasibility of this regimen in these patients. OUTLINE: Patients are stratified according to disease stage. Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1 hour on day 1, ifosfamide IV over 1 hour on days 1-3, and filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 4 and continuing until blood counts recover. Treatment repeats every 21 days for a total of 2 courses. Beginning 3 weeks after the completion of the second course of chemotherapy, patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 1 hour on day 1. Patients also receive G-CSF SC once daily on days 2-6 and again beginning on day 9 and continuing until blood counts recover. Treatment repeats every 21 days for a total of 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 3 months, every 6 months for 2 years, and then annually for 3 years. PROJECTED ACCRUAL: A total of 10-30 patients will be accrued for this study.

Official Title
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A Phase II Trial Of Adjuvant Chemotherapy For High Risk Transitional Cell Carcinoma Of The Urothelium

Conditions
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Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter

Intervention / Treatment
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* Biological: filgrastim
* Drug: carboplatin
* Drug: gemcitabine hydrochloride
* Drug: ifosfamide
* Drug: paclitaxel
* Procedure: adjuvant therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of transitional cell carcinoma of the urothelium including bladder, ureter, and renal pelvis T3b-4, N0, M0 OR Any T, N1-3, M0 Cystectomy within the past 8 weeks PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-1 Life expectancy: At least 12 months Hematopoietic: Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST or ALT no greater than 2.5 times ULN Renal: Creatinine no greater than ULN Albumin no greater than ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other prior malignancy except curatively treated carcinoma in situ of the cervix or non-melanoma skin cancer No active serious infection, other serious underlying medical condition, dementia, or significantly altered mental status that would preclude study participation No known hypersensitivity to Cremophor EL No pre-existing clinically significant grade 2 or greater neuropathy No AIDS (HIV positivity alone allowed) No known hypersensitivity to E. coli-derived products PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for malignancy No neoadjuvant chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for malignancy Surgery: See Disease Characteristics Other: No other concurrent investigational therapy
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 |
| --- |
|Biological: filgrastim|nan|
|Drug: carboplatin|nan|
|Drug: gemcitabine hydrochloride|nan|
|Drug: ifosfamide|nan|
|Drug: paclitaxel|nan|
|Procedure: adjuvant therapy|nan|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III bladder cancer, stage IV bladder cancer, transitional cell carcinoma of the bladder, localized transitional cell cancer of the renal pelvis and ureter, regional transitional cell cancer of the renal pelvis and ureter