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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 Sharp & Dohme Corp.
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00362102
First received: August 8, 2006
Last updated: April 7, 2011
Last verified: May 2008

August 8, 2006
April 7, 2011
October 2005
July 2006   (final data collection date for primary outcome measure)
Response according to the RECIST criteria accessed every 6 weeks
Same as current
Complete list of historical versions of study NCT00362102 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
A Phase II Study of Cetuximab Plus Irinotecan in Patients With EGFR-detectable Metastatic Colorectal Carcinoma
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Carcinoma
Drug: Cetuximab
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
July 2006
July 2006   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00362102
CA225-259
Not Provided
Not Provided
Bristol-Myers Squibb
Merck Sharp & Dohme Corp.
Study Director: Taku Seriu, MD Bristol Myers K.K.
Bristol-Myers Squibb
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP