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

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

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