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

NCT00063141 | Completed Phase 3

• 1 other identifier: CA225-006
• Study Type: interventional
• Target: 1,302
• Locations: 16 countries
• Sites: 184

Brief Summary

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Every 3 months after subject off-treatment

Secondary Outcomes (8)

• Progression Free Survival

  Q6 Weeks

• Response

  Q6 Weeks

• Duration of Response

  Q6 Weeks

• Time to Response

  Q6 Weeks

• Disease Control Rate

  Q6 Weeks

Study Arms (2)

Arm A

EXPERIMENTAL

Drug: cetuximab; Drug: Irinotecan

Arm B

ACTIVE COMPARATOR

Drug: Irinotecan

Interventions

cetuximab DRUG

Vial, IV, 400 mg/m² week 1 then 250 mg/m², weekly, until PD/Toxicity/Pt-PI Decision

Also known as: Erbitux

Arm A

Irinotecan DRUG

Vial, IV, 350 mg/m², Q 3 Weeks, Until PD/Toxicity/Pt-PI Decision

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Bristol-Myers Squibb: collaborator

Study Sites (188)

ImClone Investigational Site

Tucson, Arizona, 85712, United States

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Pine Bluff, Arkansas, 71603, United States

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Bakersfield, California, 93309, United States

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Berkeley, California, 94704, United States

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Beverly Hills, California, 90211, United States

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Corona, California, 92708, United States

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Gilroy, California, 95020, United States

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Greenbrae, California, 95904, United States

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Long Beach, California, 90813, United States

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Los Angeles, California, 90033, United States

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Los Angeles, California, 90057, United States

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Montebello, California, 90640, United States

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Orange, California, 92868, United States

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Palm Springs, California, 92262, United States

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Rancho Mirage, California, 92270, United States

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San Diego, California, 92120, United States

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Stockton, California, 95204, United States

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Vallejo, California, 94589, United States

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Aurora, Colorado, 80012, United States

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Denver, Colorado, 80218, United States

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New Haven, Connecticut, 06520, United States

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New London, Connecticut, 06320, United States

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Norwich, Connecticut, 06360, United States

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Stamford, Connecticut, 06902, United States

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Fort Myers, Florida, 33901, United States

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Fort Myers, Florida, 33990, United States

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Inverness, Florida, 34452, United States

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Jacksonville, Florida, 32207, United States

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Jacksonville, Florida, 32209, United States

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Jacksonville, Florida, 32224, United States

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Lakeland, Florida, 33805, United States

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Miami, Florida, 33136, United States

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New Port Richey, Florida, 34652, United States

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Orlando, Florida, 32806, United States

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Port Saint Lucie, Florida, 34952, United States

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Atlanta, Georgia, 30309, United States

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Atlanta, Georgia, 30322, United States

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Columbus, Georgia, 31902-0951, United States

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Macon, Georgia, 31201, United States

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Savannah, Georgia, 31405, United States

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Tucker, Georgia, 30342, United States

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Honolulu, Hawaii, 96813, United States

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Naperville, Illinois, 60540, United States

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South Bend, Indiana, 46601, United States

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Kansas City, Kansas, 66160, United States

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Overland Park, Kansas, 66214, United States

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Lexington, Kentucky, 40536-0098, United States

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Louisville, Kentucky, 40202, United States

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Richmond, Kentucky, 40475, United States

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Baton Rouge, Louisiana, 70808, United States

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Lafayette, Louisiana, 70506, United States

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Metairie, Louisiana, 70006, United States

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Shreveport, Louisiana, 71103, United States

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Baltimore, Maryland, 21204, United States

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Frederick, Maryland, 21701, United States

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Boston, Massachusetts, 02135, United States

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Ann Arbor, Michigan, 48106, United States

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Detroit, Michigan, 48201, United States

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Southfield, Michigan, 48075, United States

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Minneapolis, Minnesota, 55407-3799, United States

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Robbinsdale, Minnesota, 55422, United States

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Saint Louis Park, Minnesota, 55426, United States

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Jackson, Mississippi, 39202, United States

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Kansas City, Missouri, 64111, United States

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Rolla, Missouri, 65401, United States

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St Louis, Missouri, 63110, United States

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Trenton, New Jersey, 08690, United States

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Voorhees Township, New Jersey, 08084, United States

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Albany, New York, 12208, United States

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East Setauket, New York, 11733, United States

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Latham, New York, 12110, United States

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Mineola, New York, 11501, United States

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New York, New York, 10016, United States

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Rexford, New York, 12148, United States

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Stony Brook, New York, 11794, United States

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The Bronx, New York, 10466, United States

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Valhalla, New York, 10595, United States

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Durham, North Carolina, 27710, United States

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Greenville, North Carolina, 27834, United States

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High Point, North Carolina, 27262, United States

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Raleigh, North Carolina, 27609, United States

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Winston-Salem, North Carolina, 27103, United States

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Winston-Salem, North Carolina, 27157, United States

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Bismarck, North Dakota, 58501, United States

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Cincinnati, Ohio, 45267, United States

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Cleveland, Ohio, 44106, United States

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Columbus, Ohio, 43235, United States

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Dayton, Ohio, 45459, United States

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Newark, Ohio, 43055, United States

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Oklahoma City, Oklahoma, 73118, United States

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Hershey, Pennsylvania, 17033, United States

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Philadelphia, Pennsylvania, 19106, United States

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Philadelphia, Pennsylvania, 19107, United States

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Philadelphia, Pennsylvania, 19141-3098, United States

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Pittsburgh, Pennsylvania, 15232, United States

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Greenville, South Carolina, 29615, United States

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Knoxville, Tennessee, 37916, United States

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Memphis, Tennessee, 38120, United States

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Nashville, Tennessee, 37203, United States

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Austin, Texas, 78759, United States

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Dallas, Texas, 75230, United States

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Houston, Texas, 77030, United States

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Plano, Texas, 75075, United States

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Temple, Texas, 76508, United States

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Ogden, Utah, 84403, United States

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Arlington, Virginia, 22205, United States

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Danville, Virginia, 24541, United States

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Newport News, Virginia, 23606, United States

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Richmond, Virginia, 23230, United States

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Seattle, Washington, 98104, United States

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Spokane, Washington, 99204, United States

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Spokane, Washington, 99218, United States

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Walla Walla, Washington, 99362, United States

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Green Bay, Wisconsin, 54301, United States

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Madison, Wisconsin, 53792, United States

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Milwaukee, Wisconsin, 53226, United States

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Perth, Australian Capital Territory, Australia

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Sydney, Australian Capital Territory, Australia

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Sydney, New South Wales, Australia

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Wollongong, New South Wales, Australia

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South Brisbane, Queensland, Australia

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Adelaide, South Australia, Australia

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Wien, Australia

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Graz, Austria

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Salzburg, Austria

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Vienna, Austria

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Wein, Austria

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Charleroi, Belgium

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Brno, Czechia

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Olomouc, Czechia

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Prague, Czechia

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Helsinki, Finland

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Avignon, France

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Marseille, France

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Nice, France

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Saint-Herblain, France

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Aschaffenburg, Germany

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Augsburg, Germany

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Dessau, Germany

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Dortmund, Germany

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Essen, Germany

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Hamburg, Germany

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Hanburg, Germany

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Kaiserslautern, Germany

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Kassel, Germany

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Magdeburg, Germany

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Mainz, Germany

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Mannheim, Germany

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Muchnhen, Germany

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München, Germany

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Regensburg, Germany

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Saarbrücken, Germany

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Stralsund, Germany

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Stuttgart, Germany

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Hong Kong, Hong Kong

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Rozzano, Milano, Italy

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Ancona, Italy

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Bergamo, Italy

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Candiolo, Italy

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Florence, Italy

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Genova, Italy

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Livomo, Italy

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Milan, Italy

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Modena, Italy

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Napoli, Italy

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Perugia, Italy

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Reggio Emilia, Italy

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Roma, Italy

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Rome, Italy

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Apeldoorn, Netherlands

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Dordrecht, Netherlands

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Montebello, Oslo County, Norway

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Oslo, Norway

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Porto, Portugal

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Bratislava, Slovakia

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Lund, Sweden

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Stockholm, Sweden

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Bern, Switzerland

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Liestal, Switzerland

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Zurich, Switzerland

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Foresterhill, Aberdeenshire, United Kingdom

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Hull, Avon, United Kingdom

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Glasgow, Central, United Kingdom

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Poole, Dorset, United Kingdom

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London, Greater London, United Kingdom

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Bournemouth, Hampshire, United Kingdom

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Guildford, Surrey, United Kingdom

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Sutton, Surrey, United Kingdom

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MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Cetuximab; Irinotecan

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• E-mail: ClinicalTrials@ ImClone.com

  Eli Lilly and Company

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 20, 2003
• First Posted: June 25, 2003
• Study Start: April 1, 2003
• Primary Completion: June 1, 2006
• Study Completion: October 1, 2007
• Last Updated: April 12, 2010

Record last verified: 2010-04

Locations

GB (8); BE (1); NL (2); IT (14); SE (2); HK (1); PT (1); SL (1); US (116); CH (3); NO (2); FR (4); DE (18); FI (1); AU (7); CZ (3)