Phase II Trial of Neoadjuvant FOLFOX4 and Cetuximab for Localized Adenocarcinoma of Rectum
Status:
Terminated
Trial end date:
2009-11-01
Target enrollment:
Participant gender:
Summary
This study involves the use of Oxaliplatin, 5-Fluorouracil (5-FU), Leucovorin and Cetuximab,
which are all medicines approved by the Food and Drug Administration (FDA) and are
commercially available. This treatment regimen will possibly be combined with radiation
before and/or after surgery depending on your response to the treatment. Their use in this
exact combination is considered experimental. The purpose of this study is to find out how
effective this combination of chemotherapy is as treatment for rectal cancer that has not
spread to other parts of the body. The side effects and survival experienced by subjects
receiving these drugs will also be evaluated. This is a phase II research study.
Phase:
Phase 2
Details
Lead Sponsor:
University of Wisconsin, Madison
Collaborators:
Bristol-Myers Squibb Eli Lilly and Company ImClone LLC Sanofi