60
Participants
Start Date
December 31, 2006
Primary Completion Date
August 31, 2008
Study Completion Date
May 31, 2012
Bevacizumab
"Induction Treatment:~Paclitaxel 200mg/m2 by vein over 1-3 hours on Day 1 \& Day 22 Carboplatin AUC 6.0 by vein over 1 hour on Days 1 and 22 Bevacizumab 15mg/kg by vein over 60-90 minutes on Days 1 and 22 5-FU 200mg/m2 as a 24 hour continuous infusion via pump on Days 1 through 43.~Combined Modality Treatment:~Radiation therapy is given daily, Monday through Friday for approximately 7 weeks. Erlotinib 150mg by mouth daily during the entire course of radiation (approximately 7 weeks) Paclitaxel 50mg/m2 by vein over 1-hour weekly for 6 weeks beginning Day 1 of radiation therapy Bevacizumab 15mg/kg by vein over 30-90 minutes on Days 50 and 71 at the same time of radiation therapy"
Erlotinib
"Induction Treatment:~Paclitaxel 200mg/m2 by vein over 1-3 hours on Day 1 \& Day 22 Carboplatin AUC 6.0 by vein over 1 hour on Days 1 and 22 Bevacizumab 15mg/kg by vein over 60-90 minutes on Days 1 and 22 5-FU 200mg/m2 as a 24 hour continuous infusion via pump on Days 1 through 43.~Combined Modality Treatment:~Radiation therapy is given daily, Monday through Friday for approximately 7 weeks. Erlotinib 150mg by mouth daily during the entire course of radiation (approximately 7 weeks) Paclitaxel 50mg/m2 by vein over 1-hour weekly for 6 weeks beginning Day 1 of radiation therapy Bevacizumab 15mg/kg by vein over 30-90 minutes on Days 50 and 71 at the same time of radiation therapy"
Paclitaxel
"Neoadjuvant: 200 mg/m2 IV, 1-3 hour infusion, Days 1 and 22~Combined Modality: 50 mg/m2 IV, 1 hour IV infusion, weekly x6, beginning day 1 of radiation therapy"
5-FU
Neoadjuvant: 200 mg/m2 24 hour continuous infusion days 1-43
Radiation Therapy
Combined Modality Therapy: 1.8 Gy/day, Monday-Friday, total dose 68.4 Gy
Center for Cancer and Blood Disorders, Bethesda
Florida Hospital Cancer Institute, Orlando
Watson Clinic Center for Cancer Care and Research, Lakeland
Florida Cancer Specialists, Fort Myers
Tennessee Oncology, PLLC, Nashville
Chattanooga Oncology Hematology Associates, Chattanooga
Grand Rapids Clinical Oncology Program, Grand Rapids
Collaborators (1)
Genentech, Inc.
INDUSTRY
SCRI Development Innovations, LLC
OTHER