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

Tracking Information

First Received Date ^ICMJE

June 20, 2003

Last Updated Date

August 18, 2009

Start Date ^ICMJE

April 2003

Primary Completion Date

June 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

To determine if overall survival is extended using the compound in combination with chemotherapy as second line treatment.

Change History

Complete list of historical versions of study NCT00063141 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Colorectal Cancer

Intervention ^ICMJE

Drug: cetuximab
Drug: Irinotecan

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1302

Completion Date

October 2007

Primary Completion Date

June 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Austria, Belgium, Czech Republic, Finland, France, Germany, Hong Kong, Italy, Netherlands, Norway, Portugal, Slovakia, Sweden, Switzerland, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00063141

Responsible Party

Eric Rowinsky, Chief Medical Officer, ImClone Systems

Study ID Numbers ^ICMJE

CA225-006

Study Sponsor ^ICMJE

ImClone LLC

Collaborators ^ICMJE

Bristol-Myers Squibb

Investigators ^ICMJE

Study Director:

ImClone Systems

ImClone LLC

Information Provided By

ImClone LLC

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP