Efficacy Analysis of Cetuximab Plus Irinotecan in Patients With Wild-type KRAS Without Regard to Epidermal Growth Factor Receptor (EGFR) Expressions
NCT ID: NCT00637091
Last Updated: 2021-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2008-03-31
2011-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Irinotecan and Cetuximab Versus Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Cancer
NCT00063141
Cetuximab Rechallenge in Irinotecan-pretreated mCRC, KRAS, NRAS and BRAF Wild-type Treated in 1st Line With Anti-EGFR Therapy (CRICKET).
NCT02296203
A Phase II Study of Cetuximab Plus Irinotecan in Patients With EGFR-detectable Metastatic Colorectal Carcinoma
NCT00362102
Cetuximab Plus Irinotecan in Colorectal Cancer Patients Who Progressed After Failure With Cetuximab Plus Irinotecan
NCT01004159
Rechallenge of Cetuximab Combined With Irinotecan as Third-line Chemotherapy in Patients With Metastatic Colorectal Cancer - Phase II Study
NCT02316496
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
EGFR expression
Patients' accrual will be adjusted by EGFR expression (positive vs. negative)
Cetuximab, irinotecan
cetuximab, irinotecan
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cetuximab, irinotecan
cetuximab, irinotecan
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Estimated life expectancy of more than 3 months
* ECOG performance status of 0 to 1 at study entry
* Adequate bone marrow function
* Adequate liver function
* Documented progression during or within 3 months of irinotecan-containing regimens as a first-line chemotherapy
* Immunohistochemical evidence of a presence or absence of EGFR expression by PharmDx Kit
* Informed Consent
Exclusion Criteria
* Intestinal obstruction or impending intestinal obstruction due to peritoneal carcinomatosis
* Surgery (excluding biopsy for diagnosis) during 4 weeks prior to inclusion in the study.
* Evidence of gastrointestinal bleeding
* Exposure to Cetuximab
* Prior administration of monoclonal antibodies, EGFR signal transduction inhibitors or EGFR-targeted treatment
* KRAS mutant Status
* Patients with serious toxicity to previous irinotecan-based chemotherapy
* Other serious illness or medical conditions
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Asan Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Tae Won Kim
Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Asan Medical Center
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kang MJ, Hong YS, Kim KP, Kim SY, Baek JY, Ryu MH, Lee JL, Chang HM, Kim MJ, Chang HJ, Kang YK, Kim TW. Biweekly cetuximab plus irinotecan as second-line chemotherapy for patients with irinotecan-refractory and KRAS wild-type metastatic colorectal cancer according to epidermal growth factor receptor expression status. Invest New Drugs. 2012 Aug;30(4):1607-13. doi: 10.1007/s10637-011-9703-8. Epub 2011 Jun 25.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AMC-ONCGI-2008-0031
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.