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NCT00082706 · ClinicalTrials.gov registry record · Phase 2
Fluorouracil, Leucovorin, Gemcitabine, and Cisplatin in Treating Patients With Metastatic or Unresectable Adenocarcinoma of the Urothelium or Urachal Remnant
A Phase 2 study of Bladder Cancer and Urethral Cancer, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
- 1
- Study location
NCT00082706: Active Phase 2 study of Bladder Cancer and Urethral Cancer, sponsored by M.D. Anderson Cancer Center.
NCT00082706 is a Phase 2 study of Bladder Cancer and Urethral Cancer that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 46 participants, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00082706, a Phase 2 study of Bladder Cancer and Urethral Cancer, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
- 1
- Study location
Study Summary
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).
Primary Outcome
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 vo
Conditions Studied
Interventions
- DRUG Cisplatin
- DRUG Leucovorin
- DRUG 5-Fluorouracil (5-FU)
- DRUG Gemcitabine
Study Locations (1)
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2003-04-23 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 2 |
What the registry record for NCT00082706 still lists
NCT00082706 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Bladder Cancer appearing as the primary indexed condition, and to 4 interventions - of which Cisplatin is the first listed.
NCT00082706 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00082706 about?
NCT00082706 is a clinical study titled "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...
What is the current status of trial NCT00082706?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2003-04-23. Estimated completion is 2025-12-31.
What conditions does trial NCT00082706 study?
This clinical trial studies the following conditions: Bladder Cancer, Urethral Cancer, Urachal Cancer.
What interventions are being tested in trial NCT00082706?
The interventions under investigation include: Cisplatin (DRUG), Leucovorin (DRUG), 5-Fluorouracil (5-FU) (DRUG), Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT00082706?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00082706 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00082706's enrollment target sits among peer trials
46 121st of 175 higher than 53 of 175 other Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bladder Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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