45
Participants
Start Date
September 30, 2006
Primary Completion Date
April 30, 2014
Study Completion Date
May 31, 2016
cetuximab
400 mg/m2 IV Day -7 (1 week before the cycle 1, Day 1 cisplatin/5-FU and RT), then 250 mg/m2 IV Days 1, 8, 15, 22, 29, 36 and 43 (a minimum of 6 and a maximum of 8 doses of cetuximab will be administered, including the loading dose)
cisplatin
75 mg/m2 IV on Day 1 (cycle 1) and Day 29 (cycle 2)
fluorouracil
1000 mg/m2/day by continuous intravenous infusion on Days 1-4 (cycle 1) and Days 29-32 (cycle 2)
radiation therapy
Irradiation to tumor site and inguinal nodes beginning on cycle 1, Day 1 cisplatin/5-FU (minimum 45.0 Gy \[5 weeks if given on schedule and without interruption\], maximum 54.0 Gy \[6 weeks if given on schedule and without interruption). IMRT may be used at the discretion of the treating physician.
Albert Einstein Cancer Center at Albert Einstein College of Medicine, The Bronx
Joan Karnell Cancer Center at Pennsylvania Hospital, Philadelphia
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, St Louis
Benaroya Research Institute at Virginia Mason Medical Center, Seattle
Rebecca and John Moores UCSD Cancer Center, La Jolla
UCLA Clinical AIDS Research and Education (CARE) Center, Los Angeles
Beth Israel Deaconess Medical Center, Boston
National Cancer Institute (NCI)
NIH
The Emmes Company, LLC
INDUSTRY
AIDS Malignancy Consortium
NETWORK