Combination Chemotherapy Following Surgery in Treating Patients With Urinary Tract Cancer

Sponsor

Tulane University Health Sciences Center (Other)

Overall Status

Completed

CT.gov ID

NCT00028860

Collaborator

(none)

Location

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter	Biological: filgrastim Drug: carboplatin Drug: gemcitabine hydrochloride Drug: ifosfamide Drug: paclitaxel Procedure: adjuvant therapy	Phase 2

Detailed Description

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 Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2001

Actual Study Completion Date :

Oct 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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