Two-Drug Combination Chemotherapy Compared With Four-Drug Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium

June 20, 2023 updated by: Eastern Cooperative Oncology Group

Phase III Trial of Methotrexate, Vinblastine, Doxorubicin and Cisplatin vs Carboplatin and Paclitaxel in Advanced 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. It is not yet known if four-drug combination chemotherapy is more effective than two-drug combination chemotherapy in treating advanced cancer of the urothelium.

PURPOSE: Randomized phase III trial to compare the effectiveness of four-drug combination chemotherapy with that of two-drug combination chemotherapy in treating patients who have advanced cancer of the urothelium.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Compare the objective response rate, duration of remission, overall survival, and quality of life of patients with progressing regional or metastatic transitional cell carcinoma (or mixed histologies with a component of transitional cell carcinoma) of the urothelium treated with methotrexate, vinblastine, doxorubicin, and cisplatin vs carboplatin and paclitaxel. II. Compare the relative toxic effects of these treatment regimens in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive methotrexate IV on days 1, 15, and 22; vinblastine IV on days 2, 15, and 22; and cisplatin IV over 2 hours and doxorubicin IV on day 2. Treatment repeats every 28 days for a total of 6 courses in the absence of unacceptable toxicity or disease progression. Arm II: Patients receive paclitaxel IV over 3 hours immediately followed by carboplatin IV over 30 minutes. Treatment repeats every 21 days for a total of 6 courses in the absence of unacceptable toxicity or disease progression. Quality of life is assessed before treatment, before courses 2 and 4, at 4 weeks after last course, and at 10 months. Patients are followed every 3 months for 1 year and then every 6 months until disease progression.

PROJECTED ACCRUAL: A total of 330 patients will be accrued for this study within 3.3 years.

Study Type

Interventional

Enrollment (Estimated)

330

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Veterans Affairs Medical Center - Birmingham
    • California
      • La Jolla, California, United States, 92093-0658
        • University of California San Diego Cancer Center
      • San Francisco, California, United States, 94121
        • Veterans Affairs Medical Center - San Francisco
      • San Francisco, California, United States, 94115-0128
        • UCSF Cancer Center and Cancer Research Institute
    • Delaware
      • Wilmington, Delaware, United States, 19899
        • CCOP - Christiana Care Health Services
    • District of Columbia
      • Washington, District of Columbia, United States, 20307-5000
        • Walter Reed Army Medical Center
      • Washington, District of Columbia, United States, 20007
        • Lombardi Cancer Center, Georgetown University
    • Florida
      • Miami Beach, Florida, United States, 33140
        • CCOP - Mount Sinai Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Veterans Affairs Medical Center - Chicago (Westside Hospital)
      • Chicago, Illinois, United States, 60637
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago Health Sciences Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Maine
      • Togus, Maine, United States, 04330
        • Veterans Affairs Medical Center - Togus
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Veterans Affairs Medical Center - Baltimore
      • Baltimore, Maryland, United States, 21201
        • Marlene & Stewart Greenebaum Cancer Center, University of Maryland
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Memorial Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Veterans Affairs Medical Center - Minneapolis
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Cancer Center
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Veterans Affairs Medical Center - Columbia (Truman Memorial)
      • Columbia, Missouri, United States, 65203
        • Ellis Fischel Cancer Center - Columbia
      • Saint Louis, Missouri, United States, 63110
        • Barnes-Jewish Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68198-3330
        • University of Nebraska Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • CCOP - Southern Nevada Cancer Research Foundation
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Norris Cotton Cancer Center
    • New York
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute
      • Buffalo, New York, United States, 14215
        • Veterans Affairs Medical Center - Buffalo
      • Manhasset, New York, United States, 11030
        • CCOP - North Shore University Hospital
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, United States, 10021
        • New York Presbyterian Hospital - Cornell Campus
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center, NY
      • Syracuse, New York, United States, 13210
        • State University of New York - Upstate Medical University
      • Syracuse, New York, United States, 13210
        • Veterans Affairs Medical Center - Syracuse
      • Syracuse, New York, United States, 13217
        • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7295
        • Lineberger Comprehensive Cancer Center, UNC
      • Durham, North Carolina, United States, 27705
        • Veterans Affairs Medical Center - Durham
      • Durham, North Carolina, United States, 27710
        • Duke Comprehensive Cancer Center
      • Winston-Salem, North Carolina, United States, 27104-4241
        • CCOP - Southeast Cancer Control Consortium
      • Winston-Salem, North Carolina, United States, 27157-1082
        • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Arthur G. James Cancer Hospital - Ohio State University
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425-0721
        • Medical University of South Carolina
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • University of Tennessee, Memphis Cancer Center
      • Memphis, Tennessee, United States, 38104
        • Veterans Affairs Medical Center - Memphis
    • Vermont
      • Bennington, Vermont, United States, 05201
        • CCOP - Southwestern Vermont Regional Cancer Center
      • Burlington, Vermont, United States, 05401-3498
        • Vermont Cancer Center
      • White River Junction, Vermont, United States, 05009
        • Veterans Affairs Medical Center - White River Junction
    • Virginia
      • Richmond, Virginia, United States, 23298-0037
        • MBCCOP - Massey Cancer Center
      • Richmond, Virginia, United States, 23249
        • Veterans Affairs Medical Center - Richmond

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

DISEASE CHARACTERISTICS: Histologically confirmed transitional cell carcinoma of the urothelium (renal pelvis, ureter, bladder, or urethra) or mixed histologies containing a component of transitional cell carcinoma of the urothelium with manifestations of progressing regional or metastatic cancer Clinically unsuspected organ-confined prostate cancer found during cystoprostatectomy allowed Evaluable or measurable disease No significant pericardial or pleural effusion or edema No significant ascites No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: AST no greater than 2 times upper limit of normal Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.7 mg/dL Cardiovascular: No history of severe cardiovascular disease (American Heart Association class III or IV), uncontrolled congestive heart failure, or cardiac dysrhythmias Other: Prior malignancy allowed if curatively treated with no evidence of recurrence No active infection requiring parenteral antibiotics Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior systemic biologic response modifier therapy No concurrent filgrastim (G-CSF) within 24 hours prior to and after study chemotherapy administration Chemotherapy: No prior systemic chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior pelvic radiotherapy as a component of bladder-sparing therapy or as an adjuvant for locally advanced disease with positive margins No concurrent local radiotherapy for pain control or life-threatening situations Surgery: See Disease Characteristics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Cooperative Oncology Group

Collaborators

National Cancer Institute (NCI)
Cancer and Leukemia Group B

Investigators

  • Study Chair: Bruce J. Roth, MD, Vanderbilt-Ingram Cancer Center
  • Study Chair: Martin J. Edelman, MD, Veterans Affairs Medical Center - Baltimore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 1998

Primary Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

April 8, 2004

First Posted (Estimated)

April 9, 2004

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000066368
  • E4897
  • CLB-99908
  • GUMC-01011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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