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Completed Phase 3 Interventional

Study of Irinotecan and Cetuximab Versus Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Cancer

ClinicalTrials.gov ID: NCT00063141

Public ClinicalTrials.gov record NCT00063141. 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 Oct 29, 2026, 1:42 AM EDT

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

Official title

Revised Protocol 07 to Protocol CA225006 - A Phase III Randomized, Open-Label, Multicenter Study of Irinotecan and Cetuximab vs. Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Carcinoma

Brief summary

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

The purpose of this study is to determine whether overall survival is prolonged in subjects with metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with cetuximab in combination with irinotecan compared with irinotecan alone as second-line therapy following treatment with a fluoropyrimidine and oxaliplatin based, non-irinotecan-containing regimen.

Study identification

NCT ID
NCT00063141
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Eli Lilly and Company
Industry
Enrollment
1,302 participants

Conditions and interventions

Interventions

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
Apr 2003 (Type not available)
Primary completion
Jun 2006 (Actual)
Completion
Oct 2007 (Actual)
Last update posted
Apr 12, 2010

2003 – 2007

United States locations

U.S. sites
116
U.S. states
33
U.S. cities
107
Facility City State ZIP Site status
ImClone Investigational Site Tucson Arizona 85712 —
ImClone Investigational Site Pine Bluff Arkansas 71603 —
ImClone Investigational Site Bakersfield California 93309 —
ImClone Investigational Site Berkeley California 94704 —
ImClone Investigational Site Beverly Hills California 90211 —
ImClone Investigational Site Corona California 92708 —
ImClone Investigational Site Gilroy California 95020 —
ImClone Investigational Site Greenbrae California 95904 —
ImClone Investigational Site Long Beach California 90813 —
ImClone Investigational Site Los Angeles California 90033 —
ImClone Investigational Site Los Angeles California 90057 —
ImClone Investigational Site Montebello California 90640 —
ImClone Investigational Site Orange California 92868 —
ImClone Investigational Site Palm Springs California 92262 —
ImClone Investigational Site Rancho Mirage California 92270 —
ImClone Investigational Site San Diego California 92120 —
ImClone Investigational Site Stockton California 95204 —
ImClone Investigational Site Vallejo California 94589 —
ImClone Investigational Site Aurora Colorado 80012 —
ImClone Investigational Site Denver Colorado 80218 —
ImClone Investigational Site New Haven Connecticut 06520 —
ImClone Investigational Site New London Connecticut 06320 —
ImClone Investigational Site Norwich Connecticut 06360 —
ImClone Investigational Site Stamford Connecticut 06902 —
ImClone Investigational Site Fort Myers Florida 33901 —
ImClone Investigational Site Fort Myers Florida 33990 —
ImClone Investigational Site Inverness Florida 34452 —
ImClone Investigational Site Jacksonville Florida 32207 —
ImClone Investigational Site Jacksonville Florida 32209 —
ImClone Investigational Site Jacksonville Florida 32224 —
ImClone Investigational Site Lakeland Florida 33805 —
ImClone Investigational Site Miami Florida 33136 —
ImClone Investigational Site New Port Richey Florida 34652 —
ImClone Investigational Site Orlando Florida 32806 —
ImClone Investigational Site Port Saint Lucie Florida 34952 —
ImClone Investigational Site Atlanta Georgia 30309 —
ImClone Investigational Site Atlanta Georgia 30322 —
ImClone Investigational Site Columbus Georgia 31902-0951 —
ImClone Investigational Site Macon Georgia 31201 —
ImClone Investigational Site Savannah Georgia 31405 —
ImClone Investigational Site Tucker Georgia 30342 —
ImClone Investigational Site Honolulu Hawaii 96813 —
ImClone Investigational Site Naperville Illinois 60540 —
ImClone Investigational Site South Bend Indiana 46601 —
ImClone Investigational Site Kansas City Kansas 66160 —
ImClone Investigational Site Overland Park Kansas 66214 —
ImClone Investigational Site Lexington Kentucky 40536-0098 —
ImClone Investigational Site Louisville Kentucky 40202 —
ImClone Investigational Site Richmond Kentucky 40475 —
ImClone Investigational Site Baton Rouge Louisiana 70808 —
ImClone Investigational Site Lafayette Louisiana 70506 —
ImClone Investigational Site Metairie Louisiana 70006 —
ImClone Investigational Site Shreveport Louisiana 71103 —
ImClone Investigational Site Baltimore Maryland 21204 —
ImClone Investigational Site Frederick Maryland 21701 —
ImClone Investigational Site Boston Massachusetts 02135 —
ImClone Investigational Site Ann Arbor Michigan 48106 —
ImClone Investigational Site Detroit Michigan 48201 —
ImClone Investigational Site Southfield Michigan 48075 —
ImClone Investigational Site Minneapolis Minnesota 55407-3799 —
ImClone Investigational Site Robbinsdale Minnesota 55422 —
ImClone Investigational Site Saint Louis Park Minnesota 55426 —
ImClone Investigational Site Jackson Mississippi 39202 —
ImClone Investigational Site Kansas City Missouri 64111 —
ImClone Investigational Site Rolla Missouri 65401 —
ImClone Investigational Site St Louis Missouri 63110 —
ImClone Investigational Site Trenton New Jersey 08690 —
ImClone Investigational Site Voorhees Township New Jersey 08084 —
ImClone Investigational Site Albany New York 12208 —
ImClone Investigational Site East Setauket New York 11733 —
ImClone Investigational Site Latham New York 12110 —
ImClone Investigational Site Mineola New York 11501 —
ImClone Investigational Site New York New York 10016 —
ImClone Investigational Site Rexford New York 12148 —
ImClone Investigational Site Stony Brook New York 11794 —
ImClone Investigational Site The Bronx New York 10466 —
ImClone Investigational Site Valhalla New York 10595 —
ImClone Investigational Site Durham North Carolina 27710 —
ImClone Investigational Site Greenville North Carolina 27834 —
ImClone Investigational Site High Point North Carolina 27262 —
ImClone Investigational Site Raleigh North Carolina 27609 —
ImClone Investigational Site Winston-Salem North Carolina 27103 —
ImClone Investigational Site Winston-Salem North Carolina 27157 —
ImClone Investigational Site Bismarck North Dakota 58501 —
ImClone Investigational Site Cincinnati Ohio 45267 —
ImClone Investigational Site Cleveland Ohio 44106 —
ImClone Investigational Site Columbus Ohio 43235 —
ImClone Investigational Site Dayton Ohio 45459 —
ImClone Investigational Site Newark Ohio 43055 —
ImClone Investigational Site Oklahoma City Oklahoma 73118 —
ImClone Investigational Site Hershey Pennsylvania 17033 —
ImClone Investigational Site Philadelphia Pennsylvania 19106 —
ImClone Investigational Site Philadelphia Pennsylvania 19107 —
ImClone Investigational Site Philadelphia Pennsylvania 19141-3098 —
ImClone Investigational Site Pittsburgh Pennsylvania 15232 —
ImClone Investigational Site Greenville South Carolina 29615 —
ImClone Investigational Site Knoxville Tennessee 37916 —
ImClone Investigational Site Memphis Tennessee 38120 —
ImClone Investigational Site Nashville Tennessee 37203 —
ImClone Investigational Site Austin Texas 78759 —
ImClone Investigational Site Dallas Texas 75230 —
ImClone Investigational Site Houston Texas 77030 —
ImClone Investigational Site Plano Texas 75075 —
ImClone Investigational Site Temple Texas 76508 —
ImClone Investigational Site Ogden Utah 84403 —
ImClone Investigational Site Arlington Virginia 22205 —
ImClone Investigational Site Danville Virginia 24541 —
ImClone Investigational Site Newport News Virginia 23606 —
ImClone Investigational Site Richmond Virginia 23230 —
ImClone Investigational Site Seattle Washington 98104 —
ImClone Investigational Site Spokane Washington 99204 —
ImClone Investigational Site Spokane Washington 99218 —
ImClone Investigational Site Walla Walla Washington 99362 —
ImClone Investigational Site Green Bay Wisconsin 54301 —
ImClone Investigational Site Madison Wisconsin 53792 —
ImClone Investigational Site Milwaukee Wisconsin 53226 —

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

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 72 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00063141, 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 Apr 12, 2010 · Synced Oct 29, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00063141 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →