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Sponsored by: |
Asan Medical Center |
---|---|
Information provided by: | Asan Medical Center |
ClinicalTrials.gov Identifier: | NCT00637091 |
The purpose of this study is to investigate the response rate of cetuximab plus irinotecan every 2 weeks in patients harboring wild-type KRAS with and without detectable EGFR-expressing metastatic CRC after failure to irinotecan in an exploratory manner.
Condition | Intervention | Phase |
---|---|---|
Advanced Colorectal Cancer |
Drug: Cetuximab, irinotecan |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II Trial of Cetuximab Plus Irinotecan as a 2nd-Line Treatment in Patients With Metastatic Colorectal Cancer After Failure to Irinotecan That Express Wild-Type KRAS With and Without Detectable EGFR Expression |
Estimated Enrollment: | 40 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
EGFR expression: Experimental
Patients' accrual will be adjusted by EGFR expression (positive vs. negative)
|
Drug: Cetuximab, irinotecan
cetuximab, irinotecan
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Twenty patients with positive-EGFR results and 20 patients with negative-EGFR results will be accrued in this study. All patients should have wild-type KRAS.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Tae Won Kim, MD | 82-2-3010-3210 | twkimmd@amc.seoul.kr |
Korea, Republic of | |
Asan Medical Center | Recruiting |
Seoul, Korea, Republic of, 138736 | |
Contact: Tae Won Kim, MD 82-2-3010-3210 twkimmd@amc.seoul.kr |
Responsible Party: | Asan Medical Center ( Asan Medical Center ) |
Study ID Numbers: | AMC-ONCGI-2008-0031 |
Study First Received: | March 10, 2008 |
Last Updated: | March 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00637091 History of Changes |
Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Irinotecan Cetuximab Intestinal Diseases Rectal Diseases |
Intestinal Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Mitogens Antineoplastic Agents, Phytogenic Colorectal Neoplasms |
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 |