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

April 8, 2010 updated by: Eli Lilly and Company

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1302

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Wien, Australia
        • ImClone Investigational Site
    • Australian Capital Territory
      • Perth, Australian Capital Territory, Australia
        • ImClone Investigational Site
      • Sydney, Australian Capital Territory, Australia
        • ImClone Investigational Site
    • New South Wales
      • Sydney, New South Wales, Australia
        • ImClone Investigational Site
      • Wollongong, New South Wales, Australia
        • ImClone Investigational Site
    • Queensland
      • South Brisbane, Queensland, Australia
        • ImClone Investigational Site
    • South Australia
      • Adelaide, South Australia, Australia
        • ImClone Investigational Site
  • Austria
      • Graz, Austria
        • ImClone Investigational Site
      • Salzburg, Austria
        • ImClone Investigational Site
      • Wein, Austria
        • ImClone Investigational Site
      • Wien, Austria
        • ImClone Investigational Site
  • Belgium
      • Charleroi, Belgium
        • ImClone Investigational Site
  • Czech Republic
      • Brno, Czech Republic
        • ImClone Investigational Site
      • Olomouc, Czech Republic
        • ImClone Investigational Site
      • Praha 5, Czech Republic
        • ImClone Investigational Site
  • Finland
      • Helsinki, Finland
        • ImClone Investigational Site
  • France
      • Avignon, France
        • ImClone Investigational Site
      • Marseille, France
        • ImClone Investigational Site
      • Nice, France
        • ImClone Investigational Site
      • Saint Herblain, France
        • ImClone Investigational Site
  • Germany
      • Aschaffenburg, Germany
        • ImClone Investigational Site
      • Augsburg, Germany
        • ImClone Investigational Site
      • Dessau, Germany
        • ImClone Investigational Site
      • Dortmund, Germany
        • ImClone Investigational Site
      • Essen, Germany
        • ImClone Investigational Site
      • Hamburg, Germany
        • ImClone Investigational Site
      • Hanburg, Germany
        • ImClone Investigational Site
      • Kaiserslautern, Germany
        • ImClone Investigational Site
      • Kassel, Germany
        • ImClone Investigational Site
      • Magdeburg, Germany
        • ImClone Investigational Site
      • Mainz, Germany
        • ImClone Investigational Site
      • Mannheim, Germany
        • ImClone Investigational Site
      • Muchnhen, Germany
        • ImClone Investigational Site
      • Munchen, Germany
        • ImClone Investigational Site
      • Regensburg, Germany
        • ImClone Investigational Site
      • Saarbrucken, Germany
        • ImClone Investigational Site
      • Stralsund, Germany
        • ImClone Investigational Site
      • Stuttgart, Germany
        • ImClone Investigational Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • ImClone Investigational Site
  • Italy
      • Ancona, Italy
        • ImClone Investigational Site
      • Bergamo, Italy
        • ImClone Investigational Site
      • Candiolo, Italy
        • ImClone Investigational Site
      • Firenze, Italy
        • ImClone Investigational Site
      • Genova, Italy
        • ImClone Investigational Site
      • Livomo, Italy
        • ImClone Investigational Site
      • Milano, Italy
        • ImClone Investigational Site
      • Modena, Italy
        • ImClone Investigational Site
      • Napoli, Italy
        • ImClone Investigational Site
      • Perugia, Italy
        • ImClone Investigational Site
      • Reggio Emilia, Italy
        • ImClone Investigational Site
      • Roma, Italy
        • ImClone Investigational Site
      • Rome, Italy
        • ImClone Investigational Site
    • Milano
      • Rozzano, Milano, Italy
        • ImClone Investigational Site
  • Netherlands
      • Apeldorn, Netherlands
        • ImClone Investigational Site
      • Dordrecht, Netherlands
        • ImClone Investigational Site
  • Norway
      • Oslo, Norway
        • ImClone Investigational Site
    • Oslo
      • Montebello, Oslo, Norway
        • ImClone Investigational Site
  • Portugal
      • Porto, Portugal
        • ImClone Investigational Site
  • Slovakia
      • Bratislava, Slovakia
        • ImClone Investigational Site
  • Sweden
      • Lund, Sweden
        • ImClone Investigational Site
      • Stockholm, Sweden
        • ImClone Investigational Site
  • Switzerland
      • Bern, Switzerland
        • ImClone Investigational Site
      • Liestal, Switzerland
        • ImClone Investigational Site
      • Zurich, Switzerland
        • ImClone Investigational Site
  • United Kingdom
    • Aberdeenshire
      • Foresterhill, Aberdeenshire, United Kingdom
        • ImClone Investigational Site
    • Avon
      • Hull, Avon, United Kingdom
        • ImClone Investigational Site
    • Central
      • Glasgow, Central, United Kingdom
        • ImClone Investigational Site
    • Dorset
      • Poole, Dorset, United Kingdom
        • ImClone Investigational Site
    • Greater London
      • London, Greater London, United Kingdom
        • ImClone Investigational Site
    • Hampshire
      • Bournemouth, Hampshire, United Kingdom
        • ImClone Investigational Site
    • Surrey
      • Guildford, Surrey, United Kingdom
        • ImClone Investigational Site
      • Sutton, Surrey, United Kingdom
        • ImClone Investigational Site
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712
        • ImClone Investigational Site
    • Arkansas
      • Pine Bluff, Arkansas, United States, 71603
        • ImClone Investigational Site
    • California
      • Bakersfield, California, United States, 93309
        • ImClone Investigational Site
      • Berkeley, California, United States, 94704
        • ImClone Investigational Site
      • Beverly Hills, California, United States, 90211
        • ImClone Investigational Site
      • Corona, California, United States, 92708
        • ImClone Investigational Site
      • Gilroy, California, United States, 95020
        • ImClone Investigational Site
      • Greenbrae, California, United States, 95904
        • ImClone Investigational Site
      • Long Beach, California, United States, 90813
        • ImClone Investigational Site
      • Los Angeles, California, United States, 90033
        • ImClone Investigational Site
      • Los Angeles, California, United States, 90057
        • ImClone Investigational Site
      • Montebello, California, United States, 90640
        • ImClone Investigational Site
      • Orange, California, United States, 92868
        • ImClone Investigational Site
      • Palm Springs, California, United States, 92262
        • ImClone Investigational Site
      • Rancho Mirage, California, United States, 92270
        • ImClone Investigational Site
      • San Diego, California, United States, 92120
        • ImClone Investigational Site
      • Stockton, California, United States, 95204
        • ImClone Investigational Site
      • Vallejo, California, United States, 94589
        • ImClone Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80012
        • ImClone Investigational Site
      • Denver, Colorado, United States, 80218
        • ImClone Investigational Site
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • ImClone Investigational Site
      • New London, Connecticut, United States, 06320
        • ImClone Investigational Site
      • Norwich, Connecticut, United States, 06360
        • ImClone Investigational Site
      • Stamford, Connecticut, United States, 06902
        • ImClone Investigational Site
    • Florida
      • Fort Myers, Florida, United States, 33901
        • ImClone Investigational Site
      • Fort Myers, Florida, United States, 33990
        • ImClone Investigational Site
      • Inverness, Florida, United States, 34452
        • ImClone Investigational Site
      • Jacksonville, Florida, United States, 32207
        • ImClone Investigational Site
      • Jacksonville, Florida, United States, 32209
        • ImClone Investigational Site
      • Jacksonville, Florida, United States, 32224
        • ImClone Investigational Site
      • Lakeland, Florida, United States, 33805
        • ImClone Investigational Site
      • Miami, Florida, United States, 33136
        • ImClone Investigational Site
      • New Port Richey, Florida, United States, 34652
        • ImClone Investigational Site
      • Orlando, Florida, United States, 32806
        • ImClone Investigational Site
      • Port St. Lucie, Florida, United States, 34952
        • ImClone Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • ImClone Investigational Site
      • Atlanta, Georgia, United States, 30309
        • ImClone Investigational Site
      • Columbus, Georgia, United States, 31902-0951
        • ImClone Investigational Site
      • Macon, Georgia, United States, 31201
        • ImClone Investigational Site
      • Savannah, Georgia, United States, 31405
        • ImClone Investigational Site
      • Tucker, Georgia, United States, 30342
        • ImClone Investigational Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • ImClone Investigational Site
    • Illinois
      • Naperville, Illinois, United States, 60540
        • ImClone Investigational Site
    • Indiana
      • South Bend, Indiana, United States, 46601
        • ImClone Investigational Site
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • ImClone Investigational Site
      • Overland Park, Kansas, United States, 66214
        • ImClone Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0098
        • ImClone Investigational Site
      • Louisville, Kentucky, United States, 40202
        • ImClone Investigational Site
      • Richmond, Kentucky, United States, 40475
        • ImClone Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • ImClone Investigational Site
      • Lafayette, Louisiana, United States, 70506
        • ImClone Investigational Site
      • Metairie, Louisiana, United States, 70006
        • ImClone Investigational Site
      • Shreveport, Louisiana, United States, 71103
        • ImClone Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • ImClone Investigational Site
      • Frederick, Maryland, United States, 21701
        • ImClone Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • ImClone Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • ImClone Investigational Site
      • Detroit, Michigan, United States, 48201
        • ImClone Investigational Site
      • Southfield, Michigan, United States, 48075
        • ImClone Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407-3799
        • ImClone Investigational Site
      • Robbinsdale, Minnesota, United States, 55422
        • ImClone Investigational Site
      • St. Louis Park, Minnesota, United States, 55426
        • ImClone Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • ImClone Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • ImClone Investigational Site
      • Rolla, Missouri, United States, 65401
        • ImClone Investigational Site
      • St. Louis, Missouri, United States, 63110
        • ImClone Investigational Site
    • New Jersey
      • Trenton, New Jersey, United States, 08690
        • ImClone Investigational Site
      • Voorhees, New Jersey, United States, 08084
        • ImClone Investigational Site
    • New York
      • Albany, New York, United States, 12208
        • ImClone Investigational Site
      • Bronx, New York, United States, 10466
        • ImClone Investigational Site
      • East Setauket, New York, United States, 11733
        • ImClone Investigational Site
      • Latham, New York, United States, 12110
        • ImClone Investigational Site
      • Mineola, New York, United States, 11501
        • ImClone Investigational Site
      • New York, New York, United States, 10016
        • ImClone Investigational Site
      • Rexford, New York, United States, 12148
        • ImClone Investigational Site
      • Stony Brook, New York, United States, 11794
        • ImClone Investigational Site
      • Valhalla, New York, United States, 10595
        • ImClone Investigational Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • ImClone Investigational Site
      • Greenville, North Carolina, United States, 27834
        • ImClone Investigational Site
      • High Point, North Carolina, United States, 27262
        • ImClone Investigational Site
      • Raleigh, North Carolina, United States, 27609
        • ImClone Investigational Site
      • Winston-Salem, North Carolina, United States, 27157
        • ImClone Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • ImClone Investigational Site
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • ImClone Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • ImClone Investigational Site
      • Cleveland, Ohio, United States, 44106
        • ImClone Investigational Site
      • Columbus, Ohio, United States, 43235
        • ImClone Investigational Site
      • Dayton, Ohio, United States, 45459
        • ImClone Investigational Site
      • Newark, Ohio, United States, 43055
        • ImClone Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73118
        • ImClone Investigational Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • ImClone Investigational Site
      • Philadelphia, Pennsylvania, United States, 19106
        • ImClone Investigational Site
      • Philadelphia, Pennsylvania, United States, 19107
        • ImClone Investigational Site
      • Philadelphia, Pennsylvania, United States, 19141-3098
        • ImClone Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15232
        • ImClone Investigational Site
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • ImClone Investigational Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37916
        • ImClone Investigational Site
      • Memphis, Tennessee, United States, 38120
        • ImClone Investigational Site
      • Nashville, Tennessee, United States, 37203
        • ImClone Investigational Site
    • Texas
      • Austin, Texas, United States, 78759
        • ImClone Investigational Site
      • Dallas, Texas, United States, 75230
        • ImClone Investigational Site
      • Houston, Texas, United States, 77030
        • ImClone Investigational Site
      • Plano, Texas, United States, 75075
        • ImClone Investigational Site
      • Temple, Texas, United States, 76508
        • ImClone Investigational Site
    • Utah
      • Ogden, Utah, United States, 84403
        • ImClone Investigational Site
    • Virginia
      • Arlington, Virginia, United States, 22205
        • ImClone Investigational Site
      • Danville, Virginia, United States, 24541
        • ImClone Investigational Site
      • Newport News, Virginia, United States, 23606
        • ImClone Investigational Site
      • Richmond, Virginia, United States, 23230
        • ImClone Investigational Site
    • Washington
      • Seattle, Washington, United States, 98104
        • ImClone Investigational Site
      • Spokane, Washington, United States, 99204
        • ImClone Investigational Site
      • Spokane, Washington, United States, 99218
        • ImClone Investigational Site
      • Walla Walla, Washington, United States, 99362
        • ImClone Investigational Site
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • ImClone Investigational Site
      • Madison, Wisconsin, United States, 53792
        • ImClone Investigational Site
      • Milwaukee, Wisconsin, United States, 53226
        • ImClone Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically documented colorectal cancer which is EGFR-positive by immunohistochemistry [IHC] (may be based on archival samples) and is metastatic.
  • Prior oxaliplatin administered for the first-line treatment of metastatic colorectal cancer.
  • Prior fluoropyrimidine-containing regimen (5-fluorouracil [5-FU], capecitabine, or uracil/tegafur [UFT]), for the first-line treatment of metastatic disease.

Exclusion Criteria:

  • A serious uncontrolled medical disorder that, in the opinion of the Investigator, would impair the ability of the subject to receive protocol therapy
  • Unresolved diarrhea, bowel obstruction, or history of inflammatory bowel disease
  • Known or documented brain metastases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Drug: cetuximab
Vial, IV, 400 mg/m² week 1 then 250 mg/m², weekly, until PD/Toxicity/Pt-PI Decision
Other Names:
  • Erbitux
Drug: Irinotecan
Vial, IV, 350 mg/m², Q 3 Weeks, Until PD/Toxicity/Pt-PI Decision
Active Comparator: Arm B
Drug: Irinotecan
Vial, IV, 350 mg/m², Q 3 Weeks, Until PD/Toxicity/Pt-PI Decision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: Every 3 months after subject off-treatment
Every 3 months after subject off-treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival
Time Frame: Q6 Weeks
Q6 Weeks
Response
Time Frame: Q6 Weeks
Q6 Weeks
Duration of Response
Time Frame: Q6 Weeks
Q6 Weeks
Time to Response
Time Frame: Q6 Weeks
Q6 Weeks
Disease Control Rate
Time Frame: Q6 Weeks
Q6 Weeks
Safety
Time Frame: Q3 Weeks
Q3 Weeks
Quality of Life
Time Frame: Q6 Weeks
Q6 Weeks
Health Economics
Time Frame: Q3 Weeks
Q3 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Collaborators

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

June 20, 2003

First Submitted That Met QC Criteria

June 24, 2003

First Posted (Estimate)

June 25, 2003

Study Record Updates

Last Update Posted (Estimate)

April 12, 2010

Last Update Submitted That Met QC Criteria

April 8, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA225-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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