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Completed Phase 1 Interventional

Erlotinib, Modified FOLFOX6, and Bevacizumab as First-Line Therapy Metastatic Colorectal Cancer

ClinicalTrials.gov ID: NCT00118261

Public ClinicalTrials.gov record NCT00118261. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 15, 2026, 10:34 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase IB Study in Patients With Metastatic Colorectal Cancer to Evaluate Pharmacodynamic Effects of Erlotinib and Safety and Efficacy of Erlotinib in Combination With Modified FOLFOX6 (mFOLFOX6) and Bevacizumab

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, 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, 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. Erlotinib may help chemotherapy work better by making tumor cells more sensitive to the drugs. Giving erlotinib together with combination chemotherapy and bevacizumab may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib when given together with combination chemotherapy and bevacizumab as first-line therapy in treating patients with metastatic colorectal cancer.

Study identification

NCT ID
NCT00118261
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Enrollment
17 participants

Conditions and interventions

Interventions

Biological · Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 28, 2005
Primary completion
Dec 31, 2010
Completion
Dec 31, 2010
Last update posted
Sep 2, 2012

2005 – 2011

United States locations

U.S. sites
3
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Cleveland Ohio 44106-5065
MetroHealth Cancer Care Center at MetroHealth Medical Center Cleveland Ohio 44109
UHHS Chagrin Highlands Medical Center Cleveland Ohio 44122

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00118261, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 2, 2012 · Synced Sep 15, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00118261 live on ClinicalTrials.gov.

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