Treatment of Head & Neck Cancer With Chemotherapy and Radiation

PHASE2CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

August 31, 2008

Study Completion Date

May 31, 2012

Conditions
Head and Neck Cancer
Interventions
DRUG

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"

DRUG

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"

DRUG

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"

DRUG

5-FU

Neoadjuvant: 200 mg/m2 24 hour continuous infusion days 1-43

RADIATION

Radiation Therapy

Combined Modality Therapy: 1.8 Gy/day, Monday-Friday, total dose 68.4 Gy

Trial Locations (7)

20817

Center for Cancer and Blood Disorders, Bethesda

32804

Florida Hospital Cancer Institute, Orlando

33805

Watson Clinic Center for Cancer Care and Research, Lakeland

33901

Florida Cancer Specialists, Fort Myers

37023

Tennessee Oncology, PLLC, Nashville

37404

Chattanooga Oncology Hematology Associates, Chattanooga

49503

Grand Rapids Clinical Oncology Program, Grand Rapids

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

SCRI Development Innovations, LLC

OTHER