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NCT00353015 · ClinicalTrials.gov registry record · Phase 2
Irinotecan and Cisplatin for High Grade Neuroendocrine Carcinoma of the Gastrointestinal Tract
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT00353015: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00353015 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00353015, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study Summary
Primary Objective: 1\. Assess the clinical activity defined by response rate of irinotecan and cisplatin in untreated patients with metastatic or unresectable high grade neuroendocrine carcinoma of the gastrointestinal tract. Secondary Objective: 1\. To assess the safety profile of irinotecan and cisplatin in untreated patients with metastatic or unresectable high grade neuroendocrine carcinoma of the gastrointestinal tract.
Primary Outcome
Clinical activity defined by number of participants with Complete Response (CR) and Partial Response (PR) divided by total number of particpants using Response Evaluation Criteria in Solid Tumors (RECIST) where changes in tumor measurements confirmed by repeat assessments no less than 4 weeks after criteria for CR and PR responses first met.
Interventions
- DRUG Cisplatin
- DRUG Irinotecan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2003-03 |
| Est. Completion | 2009-07 |
| Phase | Phase 2 |
What the finished NCT00353015 record still lists
NCT00353015 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Cisplatin is the first listed.
NCT00353015 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00353015 about?
NCT00353015 is a clinical study titled "Irinotecan and Cisplatin for High Grade Neuroendocrine Carcinoma of the Gastrointestinal Tract". Primary Objective: 1\. Assess the clinical activity defined by response rate of irinotecan and cisplatin in untreated patients with metastatic or unresectable high grade neuroendocrine carcinoma of the gastrointestinal tract. Secondary Objective: 1\. To assess the safety profile of irinotecan and...
What is the current status of trial NCT00353015?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2003-03. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00353015?
The interventions under investigation include: Cisplatin (DRUG), Irinotecan (DRUG).
Who is sponsoring clinical trial NCT00353015?
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 NCT00353015's enrollment target sits among peer trials
21 1794th of 2000 higher than 196 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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