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Cisplatin Plus Gemcitabine With or Without Paclitaxel in Treating Patients With Stage IV Urinary Tract Cancer

NCT00022191 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 608

Last updated 2013-06-12

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective for urinary tract cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin plus gemcitabine with or without paclitaxel in treating patients who have stage IV urinary tract cancer.

Conditions

  • Bladder Cancer
  • Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Urethral Cancer

Interventions

DRUG

cisplatin

DRUG

gemcitabine hydrochloride

DRUG

paclitaxel

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Groupe D'Etude des Tumeurs Uro-Genitales

    collaborator OTHER

  • Institute of Cancer Research, United Kingdom

    collaborator OTHER

  • Central European Cooperative Oncology Group

    collaborator OTHER

  • NCIC Clinical Trials Group

    collaborator NETWORK

  • SWOG Cancer Research Network

    collaborator NETWORK

  • German Association of Urologic Oncology

    collaborator OTHER

  • Spanish Oncology Genito-Urinary Group

    collaborator OTHER

  • Medical Research Council

    collaborator OTHER_GOV

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Joaquim Bellmunt, MD, PhD · Vall d'Hebron University Hospital

  • Stephane Culine, MD · Institut du Cancer de Montpellier - Val d'Aurelle

  • Michael Leahy, MBChB, FRACP, FRCP, FRC Path · Fremantle Hospital

  • Christoph Zielinski, MD · Allgemeines Krankenhaus - Universitatskliniken

  • Malcolm J. Moore, MD · Princess Margaret Hospital, Canada

  • David C. Smith, MD · University of Michigan Rogel Cancer Center

  • Andreas Boehle, MD · Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

  • Jose Baselga, MD · Vall d'Hebron University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-05-31
Primary Completion
2004-06-30

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Denmark
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Slovakia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00022191 on ClinicalTrials.gov