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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

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

U.S. FDA Resources

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, Senior)
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


  Show 188 Study Locations
Sponsors and Collaborators
ImClone LLC
Bristol-Myers Squibb
Investigators
Study Chair: E-mail: ClinicalTrials@ ImClone.com ImClone LLC

Additional Information:
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:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Irinotecan
Camptothecin
Cetuximab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action