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NCT00321100 · ClinicalTrials.gov registry record · Phase 2

Combination of Cetuximab, Capecitabine, and Oxaliplatin With or Without Bevacizumab

A Phase 2 study, sponsored by Fox Chase Cancer Center.

Terminated
Registry status
Phase 2
Development phase
23
Enrollment target

NCT00321100: Clinical Trial Phase 2 study, sponsored by Fox Chase Cancer Center.

NCT00321100 is a Phase 2 study that was terminated before completion, run by Fox Chase Cancer Center. The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00321100, a Phase 2 study, was terminated before completion, sponsored by Fox Chase Cancer Center.

TERMINATED
Registry status
Phase 2
Development phase
23 participants
Enrollment target

Study Summary

The purpose of this study is to determine the objective response rate of patients with previously untreated metastatic colorectal cancer treated with the combination of cetuximab, capecitabine, and oxaliplatin with out without bevacizumab.

Primary Outcome

Objective response rate calculated by the proportion of overall response: CR+PR. Patients were categorized by one of the following (1-4 per RECISTv1.0 criteria on CT, MRI, x-ray; 4-9 considered failure to respond/disease progression): 1. complete response (CR): Disappearance of all lesions 2. partial response (PR): \>=30% decrease in the sum of the longest diameter of target lesions (SoL); from baseline SoL 3. stable disease (SD): Neither PR, PD, or CR 4. progressive disease (PD): \>=20% increa

Interventions

  • DRUG Capecitabine
  • DRUG Oxaliplatin
  • DRUG cetuximab
  • DRUG bevacizumab

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2006-04-12
Est. Completion 2013-12-18
Phase Phase 2
Fox Chase Cancer Center

183 total trials

Why NCT00321100 stopped before completion

NCT00321100 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).

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

NCT00321100 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00321100 about?

NCT00321100 is a clinical study titled "Combination of Cetuximab, Capecitabine, and Oxaliplatin With or Without Bevacizumab". The purpose of this study is to determine the objective response rate of patients with previously untreated metastatic colorectal cancer treated with the combination of cetuximab, capecitabine, and oxaliplatin with out without bevacizumab.

What is the current status of trial NCT00321100?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2006-04-12. Estimated completion is 2013-12-18.

What interventions are being tested in trial NCT00321100?

The interventions under investigation include: Capecitabine (DRUG), Oxaliplatin (DRUG), cetuximab (DRUG), bevacizumab (DRUG).

Who is sponsoring clinical trial NCT00321100?

This trial is sponsored by Fox Chase Cancer Center, which has 183 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00321100's enrollment target sits among peer trials

23 1784th of 2000 higher than 211 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 NCT00321100, the US trial registry maintained by the National Library of Medicine. NCT00321100 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.