Cisplatin and Docetaxel Plus Docetaxel and Radiotherapy With Amifostine for Squamous Cell Carcinoma of the Head and Neck

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

October 31, 2002

Primary Completion Date

April 30, 2007

Study Completion Date

December 31, 2007

Conditions
Cancer of Head and NeckHead CancerHead and Neck CancerNeck CancerNeck Neoplasms
Interventions
DRUG

Cisplatin

Cisplatin is given at a dose of 75 mg/m2 intravenously for three cycles on Days 1, 21, and 43.

DRUG

Docetaxel

Docetaxel is given at a dose of 75 mg/m2 intravenously on Days 1, 21, and 43 and continued at variable doses for 4 weeks with standard radiotherapy.

PROCEDURE

Radiotherapy

Radiation therapy will be given 5 days each week for 4 weeks plus a concomitant boost in the last 2 weeks of treatment to deliver 54 Gy in 30 fractions. Radiotherapy will follow the induction chemotherapy with docetaxel and cisplatin.

DRUG

Amifostine

Amifostine will be administered as a subcutaneous injection on a daily basis during radiotherapy.

Trial Locations (1)

35294

University of Alabama at Birmingham, Birmingham

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Aventis Pharmaceuticals

INDUSTRY

lead

University of Alabama at Birmingham

OTHER