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NCT00256269 · ClinicalTrials.gov registry record · Phase 2
Oxaliplatin and Irinotecan in Recurrent or Metastatic Esophageal and Gastroesophageal (GE) Junction Carcinoma
A Phase 2 study, sponsored by University of California, Irvine.
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT00256269: Clinical Trial Phase 2 study, sponsored by University of California, Irvine.
NCT00256269 is a Phase 2 study that was terminated before completion, run by University of California, Irvine. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00256269, a Phase 2 study, was terminated before completion, sponsored by University of California, Irvine.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study Summary
The combination of cisplatin and irinotecan has significant anti-tumor activity in esophageal cancer. Oxaliplatin has been shown to have activity in combination with 5-Fluorouracil (5FU) and radiation in treatment of locally advanced esophageal cancer. Oxaliplatin also has better side effects profile than cisplatin and may be able to overcome tumors that have developed cisplatin resistance. The standard treatment of locally advanced esophageal cancer has been cisplatin, 5FU and radiation followed by possible esophagectomy. However, a large portion of these patients will relapse and the tumor may develop resistance to cisplatin and/or the cumulative toxicity from previous treatment forbids the use of cisplatin again. Weekly combination of oxaliplatin and irinotecan has been shown to be active and well tolerated in elderly population with refractory colorectal cancer. Therefore, we propose this phase II trial of a weekly oxaliplatin and irinotecan to test the effectiveness and the tolerability of this regimen in metastatic and/or recurrent esophageal cancer.
Primary Outcome
To assess the overall response rate (complete and partial response) to a weekly combination of oxaliplatin and irinotecan in patients with unresectable or metastatic esophageal cancer or cancer of the gastro-esophageal (GE) junction.
Interventions
- DRUG Oxaliplatin
- DRUG Irinotecan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2005-06 |
| Est. Completion | 2007-02-07 |
| Phase | Phase 2 |
Why NCT00256269 stopped before completion
NCT00256269 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Oxaliplatin is the first listed.
NCT00256269 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00256269 about?
NCT00256269 is a clinical study titled "Oxaliplatin and Irinotecan in Recurrent or Metastatic Esophageal and Gastroesophageal (GE) Junction Carcinoma". The combination of cisplatin and irinotecan has significant anti-tumor activity in esophageal cancer. Oxaliplatin has been shown to have activity in combination with 5-Fluorouracil (5FU) and radiation in treatment of locally advanced esophageal cancer. Oxaliplatin also has better side effects profil...
What is the current status of trial NCT00256269?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2005-06. Estimated completion is 2007-02-07.
What interventions are being tested in trial NCT00256269?
The interventions under investigation include: Oxaliplatin (DRUG), Irinotecan (DRUG).
Who is sponsoring clinical trial NCT00256269?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00256269's enrollment target sits among peer trials
4 2001st of 2000 the lowest 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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