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NCT00508872 · ClinicalTrials.gov registry record · Phase 2
Folfox-B Study for Patients With Colorectal Liver Metastases
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT00508872: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00508872 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 2 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00508872, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
Objective: * To evaluate the efficacy of the use of the combination of oxaliplatin, 5-fluorouracil, leucovorin and bevacizumab (FOLFOX-B) in patients with unresectable colorectal liver metastases, with the objective to downstage hepatic disease and enable complete resection of residual disease. Primary Objective: * To evaluate the resection rate in patients with initially unresectable hepatic colorectal metastases downstaged with FOLFOX-B. Complete resection of all liver lesions is the goal. Secondary Objectives: * To evaluate the probability of complete response, partial response or stable disease. * To evaluate the proportion of patients who are resected, and the proportion of patients achieving an R0 resection (among those receiving surgery). * To correlate survival with downstaging and resection based on metastatic colorectal prognostic score. * To evaluate the disease-free survival and overall survival. * To evaluate the positron emission tomography response rate. * To explore correlations of clinical response with telomerase and hTERT expression.
Interventions
- DRUG Bevacizumab
- DRUG Leucovorin
- DRUG Oxaliplatin
- DRUG 5-Fluorouracil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2005-11 |
| Est. Completion | 2009-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00508872
The ClinicalTrials.gov registry entry for NCT00508872 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 M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Bevacizumab is the first listed.
NCT00508872 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00508872 about?
NCT00508872 is a clinical study titled "Folfox-B Study for Patients With Colorectal Liver Metastases". Objective: * To evaluate the efficacy of the use of the combination of oxaliplatin, 5-fluorouracil, leucovorin and bevacizumab (FOLFOX-B) in patients with unresectable colorectal liver metastases, with the objective to downstage hepatic disease and enable complete resection of residual disease. Pr...
What is the current status of trial NCT00508872?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2005-11. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00508872?
The interventions under investigation include: Bevacizumab (DRUG), Leucovorin (DRUG), Oxaliplatin (DRUG), 5-Fluorouracil (DRUG).
Who is sponsoring clinical trial NCT00508872?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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