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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00082706 |
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 |
Drug: cisplatin Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: leucovorin calcium |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
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 |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are stratified according to diagnosis (adenocarcinoma of the urothelium vs adenocarcinoma of the urachal remnant).
Patients receive fluorouracil 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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma* of the urothelium or urachal remnant
Measurable or evaluable disease*
Bidimensionally measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Texas | |
M. D. Anderson Cancer Center at University of Texas | Recruiting |
Houston, Texas, United States, 77030-4009 | |
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 |
Principal Investigator: | Arlene Siefker-Radtke, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000355828, MDA-ID-030111 |
Study First Received: | May 14, 2004 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00082706 |
Health Authority: | Unspecified |
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 |
Cystocele Urinary Bladder Diseases Urinary Bladder Neoplasms Leucovorin Urogenital Neoplasms Urologic Neoplasms Recurrence Carcinoma Calcium, Dietary Urethral cancer |
Cisplatin Urologic Diseases Fluorouracil Urethral Neoplasms Gemcitabine Adenocarcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial Bladder neoplasm |
Antimetabolites Anti-Infective Agents Vitamin B Complex Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Vitamins Therapeutic Uses Urethral Diseases Micronutrients |