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

This study has been completed.
Sponsor:
Collaborator:
Merck
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00362102
First received: August 8, 2006
Last updated: April 7, 2011
Last verified: May 2008
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

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
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
  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

Additional 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

No publications provided

ClinicalTrials.gov Identifier: NCT00362102     History of Changes
Other Study ID Numbers: CA225-259
Study First Received: August 8, 2006
Last Updated: April 7, 2011
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

Additional relevant MeSH terms:
Carcinoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
 Rectal Diseases
Irinotecan
Cetuximab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013