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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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Complete gross resection rate for patients with initially unresectable hepatic colorectal metastasis who are treated with a combination of oxaliplatin/ 5-fluorouracil/ leucovorin/ bevacizumab (Number of Resectable versus Not Resectable Patients).

Interventions

  • DRUG Bevacizumab
  • DRUG Leucovorin
  • DRUG Oxaliplatin
  • DRUG 5-Fluorouracil

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2005-11
Est. Completion 2009-06
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

Why NCT00508872 stopped before completion

NCT00508872 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 4 interventions - of which Bevacizumab is the first listed.

NCT00508872 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00508872's enrollment target sits among peer trials

2 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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Source: ClinicalTrials.gov NCT00508872, the US trial registry maintained by the National Library of Medicine. NCT00508872 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.