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

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 Drug: Irinotecan	Phase III

MedlinePlus related topics:

Cancer Colorectal Cancer

Drug Information available for:

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:

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
Arm A: Experimental	Drug: cetuximab Vial, IV, 400 mg/m² week 1 then 250 mg/m², weekly, until PD/Toxicity/Pt-PI Decision Drug: Irinotecan Vial, IV, 350 mg/m², Q 3 Weeks, Until PD/Toxicity/Pt-PI Decision
Arm B: Active Comparator	Drug: Irinotecan Vial, IV, 350 mg/m², Q 3 Weeks, Until PD/Toxicity/Pt-PI Decision

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

Investigators


Study Director:	ImClone Systems	ImClone Systems

More Information

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Responsible Party:	ImClone Systems ( Eric Rowinsky, Chief Medical Officer )
Study ID Numbers:	CA225006
First Received:	June 20, 2003
Last Updated:	October 27, 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 November 20, 2008

Sponsors and Collaborators:	ImClone Systems Bristol-Myers Squibb
Information provided by:	ImClone Systems
ClinicalTrials.gov Identifier:	NCT00063141