Combination Chemotherapy Following Surgery in Treating Patients With Urinary Tract Cancer

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

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 Overview

• Status: Completed
• Conditions: Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter
• Intervention / Treatment: Drug: carboplatin; Procedure: adjuvant therapy; Drug: gemcitabine hydrochloride; Drug: paclitaxel; Biological: filgrastim; Drug: ifosfamide

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 Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane Cancer Center at Tulane University Hospital and Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: Tulane University Health Sciences Center
• Investigators: Study Chair: Raja Mudad, MD, FACP, Tulane University Health Sciences Center

Study record dates

Study Major Dates

• Study Start: October 1, 2001
• Study Completion (Actual): October 1, 2004

Study Registration Dates

• First Submitted: January 4, 2002
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): July 10, 2013
• Last Update Submitted That Met QC Criteria: July 9, 2013
• Last Verified: August 1, 2004

More Information

Terms related to this study

• Keywords: stage III bladder cancer; stage IV bladder cancer; localized transitional cell cancer of the renal pelvis and ureter; transitional cell carcinoma of the bladder; regional transitional cell cancer of the renal pelvis and ureter
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Urinary Bladder Diseases; Ureteral Diseases; Kidney Neoplasms; Urinary Bladder Neoplasms; Carcinoma, Transitional Cell; Ureteral Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Alkylating; Alkylating Agents; Antineoplastic Agents, Phytogenic; Gemcitabine; Carboplatin; Paclitaxel; Ifosfamide
• Other Study ID Numbers: TULCC-RM-002; CDR0000069142 (Registry Identifier: PDQ (Physician Data Query)); AMGEN-TULCC-RM-002; BMS-TULCC-RM-002