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NCT00100841 · ClinicalTrials.gov registry record · Phase 2

Phase II Trial of FOLFOX6, Bevacizumab and Cetuximab in Patients With Colorectal Cancer

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
66
Enrollment target

NCT00100841: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT00100841 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 66 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00100841, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
66 participants
Enrollment target

Study Summary

Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab and cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab and cetuximab may kill more tumor cells. This phase II trial is studying how well giving combination chemotherapy together with bevacizumab and cetuximab works in treating patients with stage IV colorectal cancer that cannot be removed by surgery.

Primary Outcome

The primary objective is to evaluate safety in all treated patients specifically the rate of serious adverse events which were defined as grade 5 events, grade 4 hemorrhage or thrombosis or bowel perforation

Interventions

  • DRUG oxaliplatin
  • DRUG fluorouracil
  • BIOLOGICAL cetuximab
  • DRUG leucovorin calcium
  • BIOLOGICAL bevacizumab

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2004-11
Est. Completion 2011-07
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00100841 record still lists

NCT00100841 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).

The record links to 0 conditions, and to 5 interventions - of which oxaliplatin is the first listed.

NCT00100841 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00100841 about?

NCT00100841 is a clinical study titled "Phase II Trial of FOLFOX6, Bevacizumab and Cetuximab in Patients With Colorectal Cancer". Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab and cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and sp...

What is the current status of trial NCT00100841?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2004-11. Estimated completion is 2011-07.

What interventions are being tested in trial NCT00100841?

The interventions under investigation include: oxaliplatin (DRUG), fluorouracil (DRUG), cetuximab (BIOLOGICAL), leucovorin calcium (DRUG), bevacizumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT00100841?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00100841's enrollment target sits among peer trials

66 975th of 2000 higher than 1,014 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 NCT00100841, the US trial registry maintained by the National Library of Medicine. NCT00100841 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.