Fluorouracil, Leucovorin, Gemcitabine, and Cisplatin in Treating Patients With Metastatic or Unresectable Adenocarcinoma of the Urothelium or Urachal Remnant
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).
Drug: 5-Fluorouracil (5-FU)
|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|
- Number of Patients with Response [ Time Frame: Every 2 cycles (6 weeks) ] [ Designated as safety issue: No ]
- Number of Patients with Dose-Limiting Toxicity [ Time Frame: Continous assessment during 21 day cycles ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2003|
|Estimated Study Completion Date:||February 2014|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
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)
- Determine the response rate and overall survival of patients with metastatic or unresectable adenocarcinoma of the urothelium or urachal remnant treated with fluorouracil, leucovorin calcium, gemcitabine, and cisplatin.
- Determine the toxicity of this regimen in these patients.
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.
|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|