Fluorouracil, Leucovorin, Gemcitabine, and Cisplatin in Treating Patients With Metastatic or Unresectable Adenocarcinoma of the Urothelium or Urachal Remnant
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|ClinicalTrials.gov Identifier: NCT00082706|
Recruitment Status : Active, not recruiting
First Posted : May 19, 2004
Last Update Posted : November 7, 2017
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 or disease||Intervention/treatment||Phase|
|Bladder Cancer Urethral Cancer Urachal Cancer||Drug: 5-Fluorouracil (5-FU) Drug: Leucovorin Drug: Cisplatin Drug: Gemcitabine||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of 5-FU, Leucovorin, Gemcitabine, and Cisplatin for Adenocarcinomas of the Urothelial Tract and Urachal Remnant|
|Actual Study Start Date :||April 2003|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
U.S. FDA Resources
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)
- Number of Patients with Response [ Time Frame: Every 2 cycles (6 weeks) ]Complete Response: Participants counted as complete response if they have no radiological evidence of tumor, have no signs or symptoms of disease, and have normalized tumor markers (in those with initially elevated markers). Participants with an intact, tumor-containing bladder, must have a cystoscopy and exam under anesthesia to confirm a complete response. Partial response: Any response less than a complete response. Progressive disease: Progressive disease is at least 25% increase in tumor volume, or any new site of involvement, including the CNS. Increasing severity of symptoms, if judged by treating physician to be due to progressive disease, also counted as progression, even if these are not accompanied by an "objective" indicator. Any unequivocal increase (i.e. to greater than 5 mi.u./mL in beta-hCG) in a male patient taken to represent progressive disease, as will two consecutive rises amounting to a total of at least 125% of baseline for any other tumor marker.
- Number of Patients with Dose-Limiting Toxicity [ Time Frame: Continous assessment during 21 day cycles ]For each single arm trial, a stopping boundary also imposed to monitor toxicity of the new combination chemotherapy. Trial should be stopped for the 90% probability that the dose-limiting toxicity is greater than 40%. Participants monitored in groups of 3 sequentially. Stopping boundary obtained using a Bayesian monitoring rule.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00082706
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|Principal Investigator:||Arlene Siefker-Radtke, MD||M.D. Anderson Cancer Center|