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NCT00354887 · ClinicalTrials.gov registry record · Phase 2
Capecitabine and Oxaliplatin in Adenocarcinoma of the Small Bowel and Ampulla of Vater
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
NCT00354887: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00354887 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 31 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00354887, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
Study Summary
Primary Objective: 1\. To determine the objective response rate (complete plus partial) to the combination of capecitabine (Xeloda) and oxaliplatin (Eloxatin) (XELOX) in patients with adenocarcinoma of the small bowel and ampulla of Vater. Secondary objectives include determining the toxicity, time-to-treatment failure, and overall survival rates in patients treated with this combination.
Primary Outcome
Overall response rate defined as Complete Response (CR), disappearance of all target lesions; or Partial Response (PR), at least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\]. In addition to a baseline scan, confirmatory scans for those deemed to have achieved a PR or CR.
Interventions
- DRUG Capecitabine
- DRUG Oxaliplatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2004-11 |
| Est. Completion | 2009-11 |
| Phase | Phase 2 |
What the finished NCT00354887 record still lists
NCT00354887 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Capecitabine is the first listed.
NCT00354887 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00354887 about?
NCT00354887 is a clinical study titled "Capecitabine and Oxaliplatin in Adenocarcinoma of the Small Bowel and Ampulla of Vater". Primary Objective: 1\. To determine the objective response rate (complete plus partial) to the combination of capecitabine (Xeloda) and oxaliplatin (Eloxatin) (XELOX) in patients with adenocarcinoma of the small bowel and ampulla of Vater. Secondary objectives include determining the toxicity, tim...
What is the current status of trial NCT00354887?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2004-11. Estimated completion is 2009-11.
What interventions are being tested in trial NCT00354887?
The interventions under investigation include: Capecitabine (DRUG), Oxaliplatin (DRUG).
Who is sponsoring clinical trial NCT00354887?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00354887's enrollment target sits among peer trials
31 1578th of 2000 higher than 419 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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