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NCT00980239 · ClinicalTrials.gov registry record · Phase 1

HAI Irinotecan + IV Bevacizumab, Bevacizumab & Oxaliplatin or Bevacizumab & Cetuximab in Advanced Cancers Metastatic to Liver

A Phase 1 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 1
Development phase
115
Enrollment target

NCT00980239: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.

NCT00980239 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 115 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00980239, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
115 participants
Enrollment target

Study Summary

The goal of this clinical research study is to learn the highest tolerable dose of irinotecan that can be given directly into the liver, in combination with other drugs given by vein. The other drug combinations given by vein include bevacizumab alone, bevacizumab plus oxaliplatin, and bevacizumab plus cetuximab. This will be tested in patients with advanced solid tumors that have spread to the liver. The safety of these drug combinations will also be studied.

Primary Outcome

MTD is defined as the highest dose level at which ≥ 33% of patients have a DLT if \>3 patients are treated at that dose level or \> 33% have a DLT if ≤3 patients have been treated.

Interventions

  • DRUG Bevacizumab
  • DRUG Oxaliplatin
  • DRUG Cetuximab
  • DRUG Irinotecan

Trial Details

FieldValue
Enrollment Target 115 participants
Start Date 2009-09
Est. Completion 2015-08
Phase Phase 1
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT00980239 record still lists

NCT00980239 is an interventional study that assigns participants to a tested intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% higher).

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

NCT00980239 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00980239 about?

NCT00980239 is a clinical study titled "HAI Irinotecan + IV Bevacizumab, Bevacizumab & Oxaliplatin or Bevacizumab & Cetuximab in Advanced Cancers Metastatic to Liver". The goal of this clinical research study is to learn the highest tolerable dose of irinotecan that can be given directly into the liver, in combination with other drugs given by vein. The other drug combinations given by vein include bevacizumab alone, bevacizumab plus oxaliplatin, and bevacizumab ...

What is the current status of trial NCT00980239?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 115 participants. The study started on 2009-09. Estimated completion is 2015-08.

What interventions are being tested in trial NCT00980239?

The interventions under investigation include: Bevacizumab (DRUG), Oxaliplatin (DRUG), Cetuximab (DRUG), Irinotecan (DRUG).

Who is sponsoring clinical trial NCT00980239?

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 NCT00980239's enrollment target sits among peer trials

115 504th of 2000 higher than 1,494 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT00980239, the US trial registry maintained by the National Library of Medicine. NCT00980239 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.