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NCT00271011 · ClinicalTrials.gov registry record · Phase 2
A Study of Mitomycin C, Irinotecan, and Cetuximab
A Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT00271011: Clinical Trial Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
NCT00271011 is a Phase 2 study that was terminated before completion, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00271011, a Phase 2 study, was terminated before completion, sponsored by University of Michigan Rogel Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
Colorectal cancer (CRC) is one of the more common cancers in the United States with over 145,000 new cases expected in 2005. Surgery is the main treatment for CRC. However for some who relapse after surgery, or are unable to have surgery, chemotherapy is the primary treatment for this more advanced CRC. Some chemotherapy drugs are given to the patient by themselves, but many are given in combination with other chemotherapy treatment drugs and they seem to work better together than by themselves. This study will investigate the effectiveness of the combination of three chemotherapy drugs in patients who have been previously treated for their CRC and it has returned. This study will also evaluate any rash that is associated with the drug Cetuximab. The three therapy drugs are Mitomycin C, Irinotecan, and Cetuximab.
Primary Outcome
The primary objective of this single-arm phase II study is to determine the response rate (Percentage patients with Complete Response (CR) + Percentage of patients with Partial Response (PR)) for the combination of mitomycin C, irinotecan, and cetuximab in metastatic colorectal cancer with wild type K-Ras. Complete response will be defined as the disappearance of all measurable and evaluable disease for at least 4 weeks without the appearance of new lesions. Partial response will be defined as a
Interventions
- DRUG Cetuximab
- DRUG Mitomycin C
- DRUG Irinotecan.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2005-12 |
| Est. Completion | 2009-07 |
| Phase | Phase 2 |
Why NCT00271011 stopped before completion
NCT00271011 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 3 interventions - of which Cetuximab is the first listed.
NCT00271011 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00271011 about?
NCT00271011 is a clinical study titled "A Study of Mitomycin C, Irinotecan, and Cetuximab". Colorectal cancer (CRC) is one of the more common cancers in the United States with over 145,000 new cases expected in 2005. Surgery is the main treatment for CRC. However for some who relapse after surgery, or are unable to have surgery, chemotherapy is the primary treatment for this more advanced ...
What is the current status of trial NCT00271011?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2005-12. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00271011?
The interventions under investigation include: Cetuximab (DRUG), Mitomycin C (DRUG), Irinotecan. (DRUG).
Who is sponsoring clinical trial NCT00271011?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00271011's enrollment target sits among peer trials
13 1947th of 2000 higher than 53 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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