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Brief Title: A Study of Ramucirumab or Icrucumab in Colorectal Cancer
Official Title: 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 Ramucirumab 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
Study ID: NCT01111604
Brief Summary: The purpose of this study is to determine if participants with metastatic colorectal cancer live longer without their cancer progressing when treated with standard chemotherapy, standard chemotherapy plus ramucirumab, or standard chemotherapy plus icrucumab.
Detailed Description: The purpose of this study is to evaluate the progression-free survival (PFS) in participants 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 therapy. 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 participant care.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
ImClone Investigational Site, Cincinnati, Ohio, United States
ImClone Investigational Site, Columbia, South Carolina, United States
ImClone Investigational Site, Nashville, Tennessee, United States
ImClone Investigational Site, Calgary, Alberta, Canada
ImClone Investigational Site, Edmonton, Alberta, Canada
ImClone Investigational Site, Kelowna, British Columbia, Canada
ImClone Investigational Site, Surrey, British Columbia, Canada
ImClone Investigational Site, Vancouver, British Columbia, Canada
ImClone Investigational Site, Halifax, Nova Scotia, Canada
ImClone Investigational Site, Hamilton, Ontario, Canada
ImClone Investigational Site, London, Ontario, Canada
ImClone Investigational Site, Mississauga, Ontario, Canada
ImClone Investigational Site, Oshawa, Ontario, Canada
ImClone Investigational Site, Ottawa, Ontario, Canada
ImClone Investigational Site, Toronto, Ontario, Canada
ImClone Investigational Site, Windsor, Ontario, Canada
ImClone Investigational Site, Montreal, Quebec, Canada
Name: 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)
Affiliation: Eli Lilly and Company
Role: STUDY_DIRECTOR