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Trial record 31 of 45 for:    colon cancer | ( Map: Hawaii, United States )

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

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ClinicalTrials.gov Identifier: NCT00063141
Recruitment Status : Completed
First Posted : June 25, 2003
Last Update Posted : April 12, 2010
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
ImClone LLC

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: cetuximab Drug: Irinotecan Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2003
Actual Primary Completion Date : June 2006
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Every 3 months after subject off-treatment ]

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: Q6 Weeks ]
  2. Response [ Time Frame: Q6 Weeks ]
  3. Duration of Response [ Time Frame: Q6 Weeks ]
  4. Time to Response [ Time Frame: Q6 Weeks ]
  5. Disease Control Rate [ Time Frame: Q6 Weeks ]
  6. Safety [ Time Frame: Q3 Weeks ]
  7. Quality of Life [ Time Frame: Q6 Weeks ]
  8. Health Economics [ Time Frame: Q3 Weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00063141


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Locations
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United States, Arizona
ImClone Investigational Site
Tucson, Arizona, United States, 85712
United States, Arkansas
ImClone Investigational Site
Pine Bluff, Arkansas, United States, 71603
United States, California
ImClone Investigational Site
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
United States, Colorado
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Aurora, Colorado, United States, 80012
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Denver, Colorado, United States, 80218
United States, Connecticut
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New Haven, Connecticut, United States, 06520
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New London, Connecticut, United States, 06320
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Norwich, Connecticut, United States, 06360
ImClone Investigational Site
Stamford, Connecticut, United States, 06902
United States, Florida
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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
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Jacksonville, Florida, United States, 32224
ImClone Investigational Site
Lakeland, Florida, United States, 33805
ImClone Investigational Site
Miami, Florida, United States, 33136
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New Port Richey, Florida, United States, 34652
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Orlando, Florida, United States, 32806
ImClone Investigational Site
Port St. Lucie, Florida, United States, 34952
United States, Georgia
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Atlanta, Georgia, United States, 30309
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Atlanta, Georgia, United States, 30322
ImClone Investigational Site
Columbus, Georgia, United States, 31902-0951
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Macon, Georgia, United States, 31201
ImClone Investigational Site
Savannah, Georgia, United States, 31405
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Tucker, Georgia, United States, 30342
United States, Hawaii
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Honolulu, Hawaii, United States, 96813
United States, Illinois
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Naperville, Illinois, United States, 60540
United States, Indiana
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South Bend, Indiana, United States, 46601
United States, Kansas
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Kansas City, Kansas, United States, 66160
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Overland Park, Kansas, United States, 66214
United States, Kentucky
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Lexington, Kentucky, United States, 40536-0098
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Louisville, Kentucky, United States, 40202
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Richmond, Kentucky, United States, 40475
United States, Louisiana
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Baton Rouge, Louisiana, United States, 70808
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Lafayette, Louisiana, United States, 70506
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Metairie, Louisiana, United States, 70006
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Shreveport, Louisiana, United States, 71103
United States, Maryland
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Baltimore, Maryland, United States, 21204
ImClone Investigational Site
Frederick, Maryland, United States, 21701
United States, Massachusetts
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Boston, Massachusetts, United States, 02135
United States, Michigan
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Ann Arbor, Michigan, United States, 48106
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Detroit, Michigan, United States, 48201
ImClone Investigational Site
Southfield, Michigan, United States, 48075
United States, Minnesota
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Minneapolis, Minnesota, United States, 55407-3799
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Robbinsdale, Minnesota, United States, 55422
ImClone Investigational Site
St. Louis Park, Minnesota, United States, 55426
United States, Mississippi
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Jackson, Mississippi, United States, 39202
United States, Missouri
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Kansas City, Missouri, United States, 64111
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Rolla, Missouri, United States, 65401
ImClone Investigational Site
St. Louis, Missouri, United States, 63110
United States, New Jersey
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Trenton, New Jersey, United States, 08690
ImClone Investigational Site
Voorhees, New Jersey, United States, 08084
United States, New York
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Albany, New York, United States, 12208
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Bronx, New York, United States, 10466
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East Setauket, New York, United States, 11733
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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
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Rexford, New York, United States, 12148
ImClone Investigational Site
Stony Brook, New York, United States, 11794
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Valhalla, New York, United States, 10595
United States, North Carolina
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Durham, North Carolina, United States, 27710
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Greenville, North Carolina, United States, 27834
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High Point, North Carolina, United States, 27262
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Raleigh, North Carolina, United States, 27609
ImClone Investigational Site
Winston-Salem, North Carolina, United States, 27103
ImClone Investigational Site
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
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Bismarck, North Dakota, United States, 58501
United States, Ohio
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Cincinnati, Ohio, United States, 45267
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Cleveland, Ohio, United States, 44106
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Columbus, Ohio, United States, 43235
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Dayton, Ohio, United States, 45459
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Newark, Ohio, United States, 43055
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73118
United States, Pennsylvania
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Hershey, Pennsylvania, United States, 17033
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Philadelphia, Pennsylvania, United States, 19106
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Philadelphia, Pennsylvania, United States, 19107
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Philadelphia, Pennsylvania, United States, 19141-3098
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Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
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Greenville, South Carolina, United States, 29615
United States, Tennessee
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Knoxville, Tennessee, United States, 37916
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Memphis, Tennessee, United States, 38120
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Nashville, Tennessee, United States, 37203
United States, Texas
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Austin, Texas, United States, 78759
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Dallas, Texas, United States, 75230
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Houston, Texas, United States, 77030
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Plano, Texas, United States, 75075
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Temple, Texas, United States, 76508
United States, Utah
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Ogden, Utah, United States, 84403
United States, Virginia
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Arlington, Virginia, United States, 22205
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Danville, Virginia, United States, 24541
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Newport News, Virginia, United States, 23606
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Richmond, Virginia, United States, 23230
United States, Washington
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Seattle, Washington, United States, 98104
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Spokane, Washington, United States, 99204
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Spokane, Washington, United States, 99218
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Walla Walla, Washington, United States, 99362
United States, Wisconsin
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Green Bay, Wisconsin, United States, 54301
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Madison, Wisconsin, United States, 53792
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Milwaukee, Wisconsin, United States, 53226
Australia, Australian Capital Territory
ImClone Investigational Site
Perth, Australian Capital Territory, Australia
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Sydney, Australian Capital Territory, Australia
Australia, New South Wales
ImClone Investigational Site
Sydney, New South Wales, Australia
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Wollongong, New South Wales, Australia
Australia, Queensland
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South Brisbane, Queensland, Australia
Australia, South Australia
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Adelaide, South Australia, Australia
Australia
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Wien, Australia
Austria
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Graz, Austria
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Salzburg, Austria
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Wein, Austria
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Wien, Austria
Belgium
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Charleroi, Belgium
Czech Republic
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Brno, Czech Republic
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Olomouc, Czech Republic
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Praha 5, Czech Republic
Finland
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Helsinki, Finland
France
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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
Germany
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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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Munchen, Germany
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Regensburg, Germany
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Saarbrucken, Germany
ImClone Investigational Site
Stralsund, Germany
ImClone Investigational Site
Stuttgart, Germany
Hong Kong
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Hong Kong, Hong Kong
Italy
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Rozzano, Milano, Italy
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Ancona, Italy
ImClone Investigational Site
Bergamo, Italy
ImClone Investigational Site
Candiolo, Italy
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Firenze, Italy
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Genova, Italy
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Livomo, Italy
ImClone Investigational Site
Milano, 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
ImClone Investigational Site
Rome, Italy
Netherlands
ImClone Investigational Site
Apeldorn, Netherlands
ImClone Investigational Site
Dordrecht, Netherlands
Norway
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Montebello, Oslo, Norway
ImClone Investigational Site
Oslo, Norway
Portugal
ImClone Investigational Site
Porto, Portugal
Slovakia
ImClone Investigational Site
Bratislava, Slovakia
Sweden
ImClone Investigational Site
Lund, Sweden
ImClone Investigational Site
Stockholm, Sweden
Switzerland
ImClone Investigational Site
Bern, Switzerland
ImClone Investigational Site
Liestal, Switzerland
ImClone Investigational Site
Zurich, Switzerland
United Kingdom
ImClone Investigational Site
Foresterhill, Aberdeenshire, United Kingdom
ImClone Investigational Site
Hull, Avon, United Kingdom
ImClone Investigational Site
Glasgow, Central, United Kingdom
ImClone Investigational Site
Poole, Dorset, United Kingdom
ImClone Investigational Site
London, Greater London, United Kingdom
ImClone Investigational Site
Bournemouth, Hampshire, United Kingdom
ImClone Investigational Site
Guildford, Surrey, United Kingdom
ImClone Investigational Site
Sutton, Surrey, United Kingdom
Sponsors and Collaborators
ImClone LLC
Bristol-Myers Squibb
Investigators
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Study Chair: E-mail: ClinicalTrials@ ImClone.com ImClone LLC

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Responsible Party: Chief Medical Officer, ImClone Systems
ClinicalTrials.gov Identifier: NCT00063141     History of Changes
Obsolete Identifiers: NCT00065598
Other Study ID Numbers: CA225-006
First Posted: June 25, 2003    Key Record Dates
Last Update Posted: April 12, 2010
Last Verified: April 2010
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Irinotecan
Cetuximab
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological