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NCT00101348 · ClinicalTrials.gov registry record · Phase 1

Erlotinib and Cetuximab With or Without Bevacizumab in Treating Patients With Metastatic or Unresectable Kidney, Colorectal, Head and Neck, Pancreatic, or Non-Small Cell Lung Cancer

A Phase 1 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
66
Enrollment target

NCT00101348: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT00101348 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 66 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00101348, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
66 participants
Enrollment target

Study Summary

This randomized phase I/II trial studies the side effects, best way to give, and best dose of erlotinib and bevacizumab when given with cetuximab and how well giving erlotinib and cetuximab together with or without bevacizumab works in treating patients with metastatic or unresectable kidney, colorectal, head and neck, pancreatic, or non-small cell lung cancer. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab and bevacizumab, 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. Cetuximab and bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving erlotinib together with cetuximab and/or bevacizumab may kill more tumor cells.

Primary Outcome

The occurrence and maximal grade of toxicity for the whole duration of treatment will be listed and tabulated by type.

Interventions

  • OTHER laboratory biomarker analysis
  • BIOLOGICAL cetuximab
  • BIOLOGICAL bevacizumab
  • DRUG erlotinib hydrochloride

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2005-01
Est. Completion 2008-05
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00101348 record still lists

NCT00101348 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher).

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

NCT00101348 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00101348 about?

NCT00101348 is a clinical study titled "Erlotinib and Cetuximab With or Without Bevacizumab in Treating Patients With Metastatic or Unresectable Kidney, Colorectal, Head and Neck, Pancreatic, or Non-Small Cell Lung Cancer". This randomized phase I/II trial studies the side effects, best way to give, and best dose of erlotinib and bevacizumab when given with cetuximab and how well giving erlotinib and cetuximab together with or without bevacizumab works in treating patients with metastatic or unresectable kidney, colore...

What is the current status of trial NCT00101348?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2005-01. Estimated completion is 2008-05.

What interventions are being tested in trial NCT00101348?

The interventions under investigation include: laboratory biomarker analysis (OTHER), cetuximab (BIOLOGICAL), bevacizumab (BIOLOGICAL), erlotinib hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00101348?

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 NCT00101348's enrollment target sits among peer trials

66 786th of 2000 higher than 1,203 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 NCT00101348, the US trial registry maintained by the National Library of Medicine. NCT00101348 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.