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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00082706 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, gemcitabine, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving fluorouracil together with leucovorin, gemcitabine, and cisplatin works in treating patients with metastatic or unresectable adenocarcinoma of the urothelium or urachal remnant (part of the bladder).
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer Urethral Cancer Urachal Cancer |
Drug: 5-Fluorouracil (5-FU) Drug: Leucovorin Drug: Cisplatin Drug: Gemcitabine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of 5-FU, Leucovorin, Gemcitabine, and Cisplatin for Adenocarcinomas of the Urothelial Tract and Urachal Remnant |
| Estimated Enrollment: | 46 |
| Study Start Date: | April 2003 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 5-FU, Leucovorin, Gemcitabine + Cisplatin
5-FU continuous infusion over Days 1 - 5; Leucovorin once a day as a short infusion on Days 1 - 5; Cisplatin infusion over a few hours (usually 2-4 hours) once a day on Days 1 - 5; Gemcitabine infusion over 30 minutes on Days 1 & 5 only.
|
Drug: 5-Fluorouracil (5-FU)
Day: 1 - 5 Dose: 200 mg/m2 IVCI daily x 5 days
Other Names:
Drug: Leucovorin
Day: 1 - 5 Dose:10 mg/m2 daily x 5 days
Other Names:
Drug: Cisplatin
Day: 1 - 5 Dose: 20 mg/m2 daily x 5 days
Other Names:
Drug: Gemcitabine
Day: 1 & 5 Dose: 200 mg/m2 (Two doses only)
Other Names:
|
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are stratified according to diagnosis (adenocarcinoma of the urothelium vs adenocarcinoma of the urachal remnant).
Patients receive fluorouracil by vein (IV) continuously, leucovorin calcium IV once daily, and cisplatin IV once daily on days 1-5 and gemcitabine IV on days 1 and 5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3-6 months.
PROJECTED ACCRUAL: A total of 23-46 patients (7-18 with adenocarcinoma of the urachal remnant and 16-28 with adenocarcinoma of the urothelium) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| M. D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| Principal Investigator: | Arlene Siefker-Radtke, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00082706 History of Changes |
| Other Study ID Numbers: | ID03-0111, P50CA091846, P30CA016672, MDA-ID-030111, CDR0000355828 |
| Study First Received: | May 14, 2004 |
| Last Updated: | December 15, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
adenocarcinoma of the bladder recurrent bladder cancer stage IV bladder cancer recurrent urethral cancer |
anterior urethral cancer posterior urethral cancer urethral cancer associated with invasive bladder cancer stage III bladder cancer |
|
Adenocarcinoma Urinary Bladder Neoplasms Urethral Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Urinary Bladder Diseases Urologic Diseases Urethral Diseases Gemcitabine Cisplatin |
Fluorouracil Leucovorin Levoleucovorin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Vitamin B Complex Vitamins |