A Phase II Study of Cetuximab Plus Irinotecan in Patients With EGFR-Detectable Metastatic Colorectal Carcinoma - Full Text View

A Phase II Study of Cetuximab Plus Irinotecan in Patients With EGFR-Detectable Metastatic Colorectal Carcinoma

This study has been completed.

Sponsors and Collaborators:	Bristol-Myers Squibb Merck
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00362102

Purpose

To evaluate the response rate of cetuximab plus irinotecan combination therapy in subjects with EGFR-detectable metastatic colorectal carcinoma who have documented progressive disease to irinotecan-based chemotherapy and who have failed (progressive disease or intolerance) previous oxaliplatin-based and fluoropyrimidine-based chemotherapies.

Condition	Intervention	Phase
Colorectal Carcinoma	Drug: Cetuximab	Phase II

ChemIDplus related topics:

Irinotecan Irinotecan hydrochloride Cetuximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Multi-Center, Open Label, Non-Randomized, Phase II Study to Assess the Activity and Safety of Cetuximab Plus Irinotecan in Subjects With EGFR-Detectable Metastatic Colorectal Carcinoma

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Response according to the RECIST criteria accessed every 6 weeks

Secondary Outcome Measures:

Time to progression, duration of achieved response, and the disease control rate will be accessed in all patients who received Cetuximab. The worst toxicity grades per patients will be tabulated for adverse events and laboratory measurements.

Estimated Enrollment:	38
Study Start Date:	October 2005

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The subject must have surgically unresectable metastatic colorectal carcinoma.
The subjects who have received and failed Ilinotecan, oxaliplatin and fluoropyrimidine-based chemotherapy
ECOG PS 0-2

Exclusion Criteria:

Subjects with symptomatic cerebral metastasis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362102

Sponsors and Collaborators

Bristol-Myers Squibb

Merck

Investigators


Study Director:	Taku Seriu, MD	Bristol Myers K.K.

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

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

Study ID Numbers:	CA225-259
First Received:	August 8, 2006
Last Updated:	May 21, 2008
ClinicalTrials.gov Identifier:	NCT00362102
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bristol-Myers Squibb:

EGFR-detectable metastatic colorectal carcinoma with documented progressive disease to irinotecan-based chemotherapy and failure

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

Colorectal Neoplasms

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Enzyme Inhibitors

Antineoplastic Agents, Phytogenic

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008