Expired Study
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New Orleans, Louisiana 70112


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


Study summary:

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.


Criteria:

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


NCT ID:

NCT00028860


Primary Contact:

Study Chair
Raja Mudad, MD, FACP
Tulane University Health Sciences Center


Backup Contact:

N/A


Location Contact:

New Orleans, Louisiana 70112
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 15, 2017

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