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

This study has been completed.
Bristol-Myers Squibb
Information provided by:
ImClone LLC Identifier:
First received: June 20, 2003
Last updated: April 8, 2010
Last verified: April 2010
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
Drug: Irinotecan
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by ImClone LLC:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: Every 3 months after subject off-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: Q6 Weeks ] [ Designated as safety issue: No ]
  • Response [ Time Frame: Q6 Weeks ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: Q6 Weeks ] [ Designated as safety issue: No ]
  • Time to Response [ Time Frame: Q6 Weeks ] [ Designated as safety issue: No ]
  • Disease Control Rate [ Time Frame: Q6 Weeks ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: Q3 Weeks ] [ Designated as safety issue: Yes ]
  • Quality of Life [ Time Frame: Q6 Weeks ] [ Designated as safety issue: No ]
  • Health Economics [ Time Frame: Q3 Weeks ] [ Designated as safety issue: No ]

Enrollment: 1302
Study Start Date: April 2003
Study Completion Date: October 2007
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00063141

  Show 188 Study Locations
Sponsors and Collaborators
ImClone LLC
Bristol-Myers Squibb
Study Chair: E-mail: ClinicalTrials@ ImClone LLC
  More Information

Additional Information:
Responsible Party: Chief Medical Officer, ImClone Systems Identifier: NCT00063141     History of Changes
Obsolete Identifiers: NCT00065598
Other Study ID Numbers: CA225-006 
Study First Received: June 20, 2003
Last Updated: April 8, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors processed this record on April 27, 2016