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

This study has been completed.

Sponsors and Collaborators: ImClone Systems
Bristol-Myers Squibb
Information provided by: ImClone Systems
ClinicalTrials.gov Identifier: NCT00063141
  Purpose

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 Intervention Phase
Colorectal Cancer
Drug: cetuximab
Phase III

MedlinePlus related topics:   Cancer    Colorectal Cancer   

ChemIDplus related topics:   Irinotecan    Irinotecan hydrochloride    Cetuximab   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by ImClone Systems:

Primary Outcome Measures:
  • To determine if overall survival is extended using the compound in combination with chemotherapy as second line treatment

Secondary Outcome Measures:
  • To compare progression free survival, response rates, duration of response, time to response, disease control rate, safety, quality of life, and health economic resource utilization between treatment arms

Estimated Enrollment:   1300
Study Start Date:   April 2003
Study Completion Date:   October 2007

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00063141

Show 203 study locations  Show 203 Study Locations

Sponsors and Collaborators
ImClone Systems
Bristol-Myers Squibb
  More Information


Study ID Numbers:   CA225006
First Received:   June 20, 2003
Last Updated:   January 3, 2008
ClinicalTrials.gov Identifier:   NCT00063141
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Cetuximab
Irinotecan
Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008




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