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| Sponsored by: |
European Organization for Research and Treatment of Cancer |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00014274 |
Purpose
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 which combination chemotherapy regimen is most effective for transitional cell cancer of the urothelium.
PURPOSE: Randomized phase II/III trial to compare different combination chemotherapy regimens in treating patients who have transitional cell cancer of the urothelium.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer |
Drug: carboplatin Drug: gemcitabine hydrochloride Drug: methotrexate Drug: vinblastine |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | Randomized Phase II/III Study Assessing Gemcitabine/Carboplatin And Methotrexate/Carboplatin/Vinblastine In Previously Untreated Patients With Advanced Urothelial Cancer Ineligible For Cisplatin Based Chemotherapy |
| Estimated Enrollment: | 225 |
| Study Start Date: | January 2001 |
| Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
Patients in either arm who achieve a complete response (CR) receive 2 additional courses of chemotherapy beyond CR.
Quality of life is assessed at baseline, after every 2 courses of chemotherapy, and within 6 weeks of completion of therapy.
Patients are followed within 6 weeks, every 3 months for 1 year, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 156 patients (78 per treatment arm) will be accrued for the phase II portion of this study. A total of 225 patients will be accrued for the phase II + III portions of this study within 5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed transitional cell cancer of the urothelium, including the renal pelvis, ureters, urinary bladder, and urethra, meeting 1 of the following criteria:
Ineligible for cisplatin-based chemotherapy and presenting with the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations
Show 29 Study Locations| Study Chair: | Gerwin Kaiser, MD | Klinikum Nuernberg - Klinikum Nord |
More Information
| Study ID Numbers: | CDR0000068525, EORTC-GU-30986 |
| Study First Received: | April 10, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00014274 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage III bladder cancer stage IV bladder cancer transitional cell carcinoma of the bladder anterior urethral cancer |
posterior urethral cancer 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 |
|
Antimetabolites Urinary Tract Neoplasm Immunologic Factors Folate Ureteral Diseases Urogenital Neoplasms Vinblastine Urologic Neoplasms Carcinoma, Transitional Cell Vitamin B9 Renal Cancer Urologic Diseases Cisplatin Kidney Neoplasms Urethral Cancer |
Methotrexate Kidney Diseases Bladder Neoplasm Gemcitabine Kidney Cancer Cystocele Urinary Bladder Diseases Urinary Bladder Neoplasms Antimitotic Agents Carboplatin Folinic Acid Folic Acid Antagonists Antiviral Agents Immunosuppressive Agents Carcinoma |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Ureteral Diseases Urogenital Neoplasms Vinblastine Reproductive Control Agents Urologic Neoplasms Carcinoma, Transitional Cell Neoplasms by Site Urologic Diseases |
Kidney Neoplasms Therapeutic Uses Abortifacient Agents Urethral Diseases Methotrexate Kidney Diseases Gemcitabine Dermatologic Agents Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Mitosis Modulators Urinary Bladder Diseases Urinary Bladder Neoplasms Enzyme Inhibitors Antimitotic Agents |