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NCT01004159 · ClinicalTrials.gov registry record · Phase 2

Cetuximab Plus Irinotecan in Colorectal Cancer Patients Who Progressed After Failure With Cetuximab Plus Irinotecan

A Phase 2 study, sponsored by Roswell Park Cancer Institute.

Terminated
Registry status
Phase 2
Development phase
20
Enrollment target

NCT01004159: Clinical Trial Phase 2 study, sponsored by Roswell Park Cancer Institute.

NCT01004159 is a Phase 2 study that was terminated before completion, run by Roswell Park Cancer Institute. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01004159, a Phase 2 study, was terminated before completion, sponsored by Roswell Park Cancer Institute.

TERMINATED
Registry status
Phase 2
Development phase
20 participants
Enrollment target

Study Summary

This study is being performed to test if the use of high dose of cetuximab in combination with irinotecan overcomes the resistance seen with standard dose of cetuximab plus irinotecan in patients with wild type KRS tumors that have advanced colon or rectal cancer

Interventions

  • DRUG cetuximab with irinotecan

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2009-09
Est. Completion 2012-05
Phase Phase 2
Roswell Park Cancer Institute

365 total trials

Why NCT01004159 stopped before completion

NCT01004159 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).

The record links to 0 conditions, and to 1 intervention - of which cetuximab with irinotecan is the first listed.

NCT01004159 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01004159 about?

NCT01004159 is a clinical study titled "Cetuximab Plus Irinotecan in Colorectal Cancer Patients Who Progressed After Failure With Cetuximab Plus Irinotecan". This study is being performed to test if the use of high dose of cetuximab in combination with irinotecan overcomes the resistance seen with standard dose of cetuximab plus irinotecan in patients with wild type KRS tumors that have advanced colon or rectal cancer

What is the current status of trial NCT01004159?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2009-09. Estimated completion is 2012-05.

What interventions are being tested in trial NCT01004159?

The interventions under investigation include: cetuximab with irinotecan (DRUG).

Who is sponsoring clinical trial NCT01004159?

This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01004159's enrollment target sits among peer trials

20 1805th of 2000 higher than 107 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 NCT01004159, the US trial registry maintained by the National Library of Medicine. NCT01004159 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.