NCT00462735View on ClinicalTrials.gov

Fluorouracil, Hydroxyurea, Cetuximab and Twice-daily Intensity Radiation Therapy for Advanced Head and Neck Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

February 28, 2007

Primary Completion Date

October 31, 2010

Study Completion Date

October 31, 2010

Conditions
Head and Neck CancerCancer of the PharynxCancer of the LarynxNose NeoplasmsParanasal Sinus NeoplasmsCancer of the Oral Cavity
Interventions
DRUG

Cetuximab

250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients

DRUG

Hydroxyurea

500 mg orally every 12 hours with the morning dose administered 2 hours before radiation

DRUG

Fluorouracil

continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours

PROCEDURE

radiotherapy

"Radiotherapy was administered at 1.5 Gy per fraction twice daily with treatments separated by at least 6 hours on Days 1 through 5 on an alternating week schedule.~Radiation was delivered with intensity-modulated radiation therapy (IMRT) planning for all patients."

Trial Locations (1)

10029

Mount Sinai School of Medicine, New York

All Listed Sponsors
lead

Johnny Kao

OTHER

NCT00462735 - Fluorouracil, Hydroxyurea, Cetuximab and Twice-daily Intensity Radiation Therapy for Advanced Head and Neck Cancer | Biotech Hunter | Biotech Hunter