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NCT00106054 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Colorectal Cancer With Unresectable Liver Metastases
A Phase 2 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT00106054 is a Phase 2 study that was terminated before completion, run by Pfizer. The registered enrollment target is 2 participants.
The verdict
NCT00106054, a Phase 2 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
The study was terminated early due to low enrollment with only 2 subjects enrolled and treated after being open for enrollment for over a year. Therefore, no meaningful efficacy analyses could be performed. This trial is studying the effects (good and bad) of a combination of drugs, Irinotecan in combination with infusional 5-FU, leucovorin (FOLFIFI) plus Bevacizumab, for cancer of the colon or rectum that has spread to the liver only and is currently not able to be removed by surgery. All of the drugs that will be received in this research study have been approved in the United States for colorectal cancer, that has spread to other areas of the body, including the liver. Another reason for doing this study is to see if the chemotherapy drugs FOLFIFI plus Bevacizumab can sufficiently decrease the size of the cancer in the liver so that any tumor remaining can be completely removed with surgery and, if it can be removed whether doing so will prolong the time it takes the cancer to return and/or prolong the life of these patients. This trial is also looking at the genes of people who take part in this study, to see if it is possible to find out characteristics that can help predict whose cancer will respond well or not so well, and who will have more or less side effects to this chemotherapy.
Interventions
- DRUG Combination therapy of irinotecan with 5-FU, leucovorin plus bevacizumab in the neoadjuvant setting.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2006-01 |
| Est. Completion | 2006-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00106054
The ClinicalTrials.gov registry entry for NCT00106054 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Combination therapy of irinotecan with 5-FU, leucovorin plus bevacizumab in the neoadjuvant setting. is the first listed.
NCT00106054 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00106054 about?
NCT00106054 is a clinical study titled "Neoadjuvant Colorectal Cancer With Unresectable Liver Metastases". The study was terminated early due to low enrollment with only 2 subjects enrolled and treated after being open for enrollment for over a year. Therefore, no meaningful efficacy analyses could be performed. This trial is studying the effects (good and bad) of a combination of drugs, Irinotecan in c...
What is the current status of trial NCT00106054?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2006-01. Estimated completion is 2006-09.
What interventions are being tested in trial NCT00106054?
The interventions under investigation include: Combination therapy of irinotecan with 5-FU, leucovorin plus bevacizumab in the neoadjuvant setting. (DRUG).
Who is sponsoring clinical trial NCT00106054?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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