20
Participants
Start Date
January 31, 2010
Primary Completion Date
July 31, 2013
Study Completion Date
November 30, 2014
cetuximab
500 mg/m2 IV every two weeks on days 1, 15, 29, and 43 of each 56 day cycle, for a total of 3 cycles. Cetuximab dose will be escalated by 100 mg/m2 every 2 weeks to a maximum dose of 800 mg/m2 if, at the time of retreatment, skin rash is less than or equal to grade 1, diarrhea is grade 0 (defined as less than or equal to 3 stools per day over baseline), and the patient is not experiencing any other greater than or equal to grade 2 toxicity attributed to cetuximab.
5-FU
3000 mg/m2 IV continuous infusion over 46 hours every two weeks on days 1, 15, 29, and 43 of each 56 day cycle, for a total of 3 cycles.
oxaliplatin
85 mg/m2 IV every two weeks on days 1, 15, 29, and 43 of each 56 day cycle, for a total of 3 cycles.
leucovorin
400 mg/m2 IV every two weeks on days 1, 15, 29, and 43 of each 56 day cycle, for a total of 3 cycles.
Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh
NSABP Foundation, Inc., Pittsburgh
Thomas Jefferson University Hospital, Philadelphia
CCOP - Christiana Care Health Services, Newark
Franklin Square Hospital Center, Baltimore
CCOP - Upstate Carolina, Spartanburg
M.D. Anderson Cancer Center - Orlando, Orlando
CCOP, Dayton, OH, Dayton
CCOP, William Beaumont Hospital, Royal Oak
Henry Ford Health System, Detroit
CCOP - Grand Rapids Clinical Oncology Program, Grand Rapids
University of Iowa, Iowa City
Medical College of Wisconsin, Milwaukee
CCOP - Metro-Minnesota, Saint Louis Park
CCOP - NorthShore University HealthSystem, Evanston
Edward Hospital, Naperville
Kaiser Permanente-San Diego, San Diego
Loma Linda University Medical Center, Loma Linda
St. Joseph Hospital, Orange
Kaiser Permanente Medical Center - Vallejo, Vallejo
NortonHealthcare, Inc., Louisville
University of Pittsburgh, Pittsburgh
Vermont Cancer Center at University of Vermont, Burlington
Collaborators (1)
Bristol-Myers Squibb
INDUSTRY
NSABP Foundation Inc
NETWORK