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NCT00256321 · ClinicalTrials.gov registry record · Phase 2
Celecoxib/Oxaliplatin/Capecitabine for Gastric/Gastroesophageal Junction Carcinoma
A Phase 2 study, sponsored by University of California, Irvine.
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT00256321: Clinical Trial Phase 2 study, sponsored by University of California, Irvine.
NCT00256321 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
NCT00256321, 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
Gastric cancer is the second most common neoplasm in the world. Early diagnosis and surgical resection improve the survival and the chance of cure. Unfortunately, majority of cases are diagnosed at advanced stage, with only 20% of the patients presenting with localized disease. The five-year survival for gastric cancer of all stages remains at a dismal 8%. Chemotherapy has been used for advanced gastric cancer but with unsatisfactory results. Therefore, new approaches are needed for these patients. Among the newer chemotherapy regimens for advanced gastric cancer include a combination of oral 5-Fluoro-Uracil (FU)-based compound called Capecitabine(Xeloda) and Oxaliplatin. A few phase II studies suggest that the combination regimen is active with overall response rates ranging 30-40%. Several preclinical and clinical studies have shown that the expression of cyclooxygenase enzyme II(COX-2) is upregulated in many pre-neoplastic and neoplastic lesions. Furthermore, there appears to be an association with the overexpression of Cox-2 and the invasiveness of cancer and prognosis. Finally, preclinical and clinical studies suggest selective Cox-2 inhibitors can induce apoptosis in gastric cancer cells and retard tumor progression. Therefore, there is a strong rationale for the combination of a selective Cox-2 inhibitor, Celecoxib, with Capecitabine and Oxaliplatin in a therapeutic phase II trial for patients with advanced or recurrent gastric cancer.
Primary Outcome
Complete Response (CR) Complete disappearance of all measurable and evaluable disease. No new lesions. No disease related symptoms. No evidence of non evaluable disease, including normalization of markers and other abnormal lab values. All measurable, evaluable and non evaluable lesions and sites must be assessed using the same techniques as baseline. Partial Response (PR): Applies only to patients with at least one measurable lesion. Greater than or equal to 50% decrease under baseline in the
Interventions
- DRUG Capecitabine
- DRUG Oxaliplatin
- DRUG Celecoxib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2004-10 |
| Est. Completion | 2007-08 |
| Phase | Phase 2 |
Why NCT00256321 stopped before completion
NCT00256321 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 3 interventions - of which Capecitabine is the first listed.
NCT00256321 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00256321 about?
NCT00256321 is a clinical study titled "Celecoxib/Oxaliplatin/Capecitabine for Gastric/Gastroesophageal Junction Carcinoma". Gastric cancer is the second most common neoplasm in the world. Early diagnosis and surgical resection improve the survival and the chance of cure. Unfortunately, majority of cases are diagnosed at advanced stage, with only 20% of the patients presenting with localized disease. The five-year surviva...
What is the current status of trial NCT00256321?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2004-10. Estimated completion is 2007-08.
What interventions are being tested in trial NCT00256321?
The interventions under investigation include: Capecitabine (DRUG), Oxaliplatin (DRUG), Celecoxib (DRUG).
Who is sponsoring clinical trial NCT00256321?
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 NCT00256321'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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