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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.
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
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 ]

Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: Q6 Weeks ]
  • Response [ Time Frame: Q6 Weeks ]
  • Duration of Response [ Time Frame: Q6 Weeks ]
  • Time to Response [ Time Frame: Q6 Weeks ]
  • Disease Control Rate [ Time Frame: Q6 Weeks ]
  • Safety [ Time Frame: Q3 Weeks ]
  • Quality of Life [ Time Frame: Q6 Weeks ]
  • Health Economics [ Time Frame: Q3 Weeks ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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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

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 22, 2017