Combination Chemotherapy Following Surgery in Treating Patients With Urinary Tract Cancer

Tulane University Health Sciences Center

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter

Interventions

filgrastimBIOLOGICAL

carboplatinDRUG

gemcitabine hydrochlorideDRUG

ifosfamideDRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Tulane Cancer Center at Tulane University Hospital and Clinic

New Orleans, Louisiana, United States

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.