An Open-label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of 5 FU/FA and Oxaliplatin (Modified FOLFOX 6) in Combination With IMC-1121B or IMC-18F1 or Without Investigational Therapy as Second Line Therapy in Patients With Metastatic Colorectal Cancer Following Disease Progression on First Line Irinotecan-based Therapy
The purpose of this study is to evaluate the progression-free survival (PFS) in patients
with metastatic colorectal cancer when treated with 1 of 3 modified FOLFOX-6 (folinic acid
[FA] + fluorouracil [5-FU] + oxaliplatin [mFOLFOX-6])-based regimens, as second-line
During 2010, there has been an identified shortage of injectable folinic acid (FA) in the
United States. Levo-folinic acid (LFA) will be allowed as a substitute for FA in the
mFOLFOX-6 chemotherapy regimen in circumstances in which FA is not available, to facilitate
continuity of patient care.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival (PFS)
PFS is defined as the time from the date of randomization until the date of objectively determined progression as defined by RECIST v1.1, or death from any cause, whichever is first.
Canada: Health Canada
|ImClone Investigational Site||Cleveland, Ohio 44134|
|ImClone Investigational Site||Greenville, South Carolina 29605|
|ImClone Investigational Site||Memphis, Tennessee 38104|