Clinical trialNCT00003376CompletedPhase 3Interventional

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

SponsorEastern Cooperative Oncology GroupEnrollment330Bladder CancerTransitional Cell Cancer of the Renal Pelvis and UreterUrethral Cancer

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Bruce J. Roth, MD
Vanderbilt-Ingram Cancer Center
Study Chair
clinicaltrials.gov ↗
Martin J. Edelman, MD
Veterans Affairs Medical Center - Baltimore
Study ChairKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

50 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, United States
University of California San Diego Cancer Center
La Jolla, California, United States
Ucsf Cancer Center and Cancer Research Institute
San Francisco, California, United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States
Ccop - Christiana Care Health Services
Wilmington, Delaware, United States
Lombardi Cancer Center, Georgetown University
Washington D.C., District of Columbia, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Ccop - Mount Sinai Medical Center
Miami Beach, Florida, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
University of Illinois at Chicago Health Sciences Center
Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (westside Hospital)
Chicago, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Veterans Affairs Medical Center - Togus
Togus, Maine, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States
Veterans Affairs Medical Center - Columbia (truman Memorial)
Columbia, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Ccop - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States
Ccop - North Shore University Hospital
Manhasset, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Mount Sinai Medical Center, Ny
New York, New York, United States
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States
Ccop - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States
State University of New York - Upstate Medical University
Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States
Lineberger Comprehensive Cancer Center, Unc
Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States
Ccop - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States

10 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Carboplatin →Cisplatin →Doxorubicin →Methotrexate →Paclitaxel →Vinblastine

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 3 Dec 1998
Primary completion: 30 Sept 2005
Completion: —
Last update posted: 22 Jun 2023
Registered enrollment: 330
Registry id: NCT00003376

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.