Back to resultsA Phase II Study of Cetuximab Plus Irinotecan in Patients With EGFR-detectable Metastatic Colorectal Carcinoma
Primary Purpose
Colorectal Carcinoma
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cetuximab
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Carcinoma focused on measuring EGFR-detectable metastatic colorectal carcinoma with documented progressive disease to irinotecan-based chemotherapy and failure
Eligibility 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
Sites / Locations
Outcomes
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.
Full Information
NCT ID
NCT00362102
First Posted
August 8, 2006
Last Updated
November 21, 2016
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00362102
Brief Title
A Phase II Study of Cetuximab Plus Irinotecan in Patients With EGFR-detectable Metastatic Colorectal Carcinoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Carcinoma
Keywords
EGFR-detectable metastatic colorectal carcinoma with documented progressive disease to irinotecan-based chemotherapy and failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Primary Outcome Measure Information:
Title
Response according to the RECIST criteria accessed every 6 weeks
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
18836202
Citation
Tahara M, Shirao K, Boku N, Yamaguchi K, Komatsu Y, Inaba Y, Arai T, Mizunuma N, Satoh T, Takiuchi H, Nishina T, Sakata Y. Multicenter Phase II study of cetuximab plus irinotecan in metastatic colorectal carcinoma refractory to irinotecan, oxaliplatin and fluoropyrimidines. Jpn J Clin Oncol. 2008 Nov;38(11):762-9. doi: 10.1093/jjco/hyn102. Epub 2008 Oct 4.
Results Reference
result
Learn more about this trial
A Phase II Study of Cetuximab Plus Irinotecan in Patients With EGFR-detectable Metastatic Colorectal Carcinoma
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