Home
Search
Study Topics
Glossary
|
Study 20 of 344 for search of: | Canada, New Brunswick |
Previous Study | Return to Search Results | Next Study |
|
|
|
|
|
Sponsors and Collaborators: |
European Organization for Research and Treatment of Cancer National Cancer Institute (NCI) Groupe D'Etude des Tumeurs Uro-Genitales Institute of Cancer Research, United Kingdom Central European Cooperative Oncology Group National Cancer Institute of Canada Southwest Oncology Group German Association of Urologic Oncology Spanish Oncology Genito-Urinary Group Medical Research Council |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00022191 |
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.
Condition | Intervention | Phase |
---|---|---|
Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer |
Drug: cisplatin Drug: gemcitabine hydrochloride Drug: paclitaxel |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | Randomized Phase III Study Comparing Paclitaxel/Cisplatin/Gemcitabine and Cisplatin/Gemcitabine in Patients With Metastatic or Locally Advanced Urothelial Cancer Without Prior Systemic Therapy |
Study Start Date: | May 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center, WHO performance status (0 vs 1), and presence of metastatic disease (yes vs no). Patients are randomized to one of two treatment arms.
Patients are followed every 3 months for 2 years and then every 6 months for at least 3 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 610 patients (305 per treatment arm) will be accrued for this study within 3.04 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed stage IV transitional cell carcinoma of the urothelium (pure or mixed) including bladder, urethra, ureter, and renal pelvis
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study Chair: | Joaquim Bellmunt, MD, PhD | Vall d'Hebron University Hospital |
Study Chair: | Stephane Culine, MD | Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle |
Study Chair: | Michael Leahy, MBChB, FRACP, FRCP, FRC Path | Fremantle Hospital |
Study Chair: | Christoph Zielinski, MD | Allgemeines Krankenhaus - Universitatskliniken |
Study Chair: | Malcolm J. Moore, MD | Princess Margaret Hospital, Canada |
Study Chair: | David C. Smith, MD | University of Michigan Cancer Center |
Study Chair: | Andreas Boehle, MD | Universitaetsklinikum Schleswig-Holstein - Campus Luebeck |
Study Chair: | Jose Baselga, MD | Vall d'Hebron University Hospital |
Study Chair: | Michael Leahy, MBChB, FRACP, FRCP, FRC Path | Fremantle Hospital |
Study ID Numbers: | CDR0000068793, EORTC-30987, CAN-NCIC-BL7, CECOG-EORTC-30987, GAUO-EORTC-30987, GETUG-EORTC-30987, SOGUG-EORTC-30987, SWOG-30987, NCRI-CRUK-BA11, MRC-BA11 |
Study First Received: | August 10, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00022191 |
Health Authority: | United States: Federal Government |
stage IV bladder cancer transitional cell carcinoma of the bladder urethral cancer associated with invasive bladder cancer metastatic transitional cell cancer of the renal pelvis and ureter regional transitional cell cancer of the renal pelvis and ureter |
Cystocele Urinary Bladder Diseases Urinary Bladder Neoplasms Ureteral Diseases Urogenital Neoplasms Renal cancer Kidney cancer Carcinoma, Transitional Cell Urologic Neoplasms Transitional cell carcinoma Carcinoma Urethral cancer |
Cisplatin Urologic Diseases Paclitaxel Kidney Neoplasms Urethral Neoplasms Kidney Diseases Gemcitabine Ureteral Neoplasms Urinary tract neoplasm Bladder neoplasm Neoplasms, Glandular and Epithelial |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Enzyme Inhibitors Antimitotic Agents |
Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Tubulin Modulators Urethral Diseases Antineoplastic Agents, Phytogenic |