A Phase II III Study of MK0646 Treatment in Combination With Cetuximab and Irinotecan For Patients With Metastatic Colorectal Cancer
18 Years
N/A
Both
Metastatic Colorectal Cancer
Trial Information
A Phase II III Study of MK0646 Treatment in Combination With Cetuximab and Irinotecan For Patients With Metastatic Colorectal Cancer
Dalotuzumab is a humanized monoclonal antibody (mAb) that targets the insulin-like growth
factor type 1 receptor-1 (IGF-1R).
Dalotuzumab may act through:
Inhibition of insulin-like growth factor-1 (IGF-1)-mediated cell signaling to cause
reductions in tumor growth and spread Antibody dependent cell-mediated cytotoxicity
In preclinical studies, dalotuzumab improved the activity of an anti-epidermal growth factor
receptor (EGFR) mAb and the activity of Erlotinib, a small molecule inhibitor of EGFR.
All eligible participants will receive cetuximab 400 mg/m2 infusion over 120 minutes
followed by weekly infusions of 250 mg/m2 over 60-120 minutes along with irinotecan infusion
over 30-90 minutes. Dosage of irinotecan will be the same as most recent pre-study therapy.
Participants will then be assigned to one of 3 treatment arms.
Inclusion Criteria:
- You must have confirmed KRAS wild type colorectal cancer.
- You must have previously failed both irinotecan and oxaliplatin containing regimens,
and should have progressed on or within 3 months of completing your last line of
therapy with objective evidence of progression as verified by previous radiologic
scans.
Exclusion Criteria:
- You have had cancer treatment within 2 weeks before the first dose of study drug(s)
or if the side effects from the drugs have not gone down to a certain level 2 weeks
before the first dose of study drugs.
- You have had a bad side effect to irinotecan therapy.
- You have human immunodeficiency virus (HIV).
- You have Hepatitis B or C.
- You are pregnant or breast feeding or planning to have a child while on this study.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
Overall survival.
Outcome Time Frame:
Every three months
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
MK-0646-004
NCT ID:
NCT00614393
Start Date:
December 2007
Completion Date:
March 2012
Related Keywords:
- Metastatic Colorectal Cancer
- Colorectal Neoplasms
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