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

Sponsors and Collaborators:	ImClone LLC Bristol-Myers Squibb
Information provided by:	ImClone LLC
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 Drug: Irinotecan	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Irinotecan U 101440E Irinotecan hydrochloride Cetuximab

U.S. FDA Resources

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
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 LLC

Bristol-Myers Squibb

Investigators

Study Director:

ImClone Systems

ImClone LLC

More Information

Additional 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

No publications provided

Responsible Party:	ImClone Systems ( Eric Rowinsky, Chief Medical Officer )
Study ID Numbers:	CA225006
Study First Received:	June 20, 2003
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00063141 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Irinotecan
Cetuximab
Intestinal Diseases
Rectal Diseases

Intestinal Neoplasms
Carcinoma
Digestive System Diseases
Gastrointestinal Neoplasms
Antineoplastic Agents, Phytogenic
Colorectal Neoplasms

Additional relevant MeSH terms:

Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Colonic Diseases
Irinotecan
Cetuximab
Enzyme Inhibitors
Intestinal Diseases
Rectal Diseases

Pharmacologic Actions
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Neoplasms
Antineoplastic Agents, Phytogenic
Colorectal Neoplasms

ClinicalTrials.gov processed this record on July 02, 2009