A Phase II Trial Neoadjuvant Paclitaxel and Cisplatin in Patients With Locally Advanced Head and Neck Cancer

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

May 31, 2005

Primary Completion Date

June 30, 2007

Study Completion Date

June 30, 2007

Conditions
Head and Neck Cancer
Interventions
DRUG

Paclitaxel

Sterile solution mixed with 0.9% saline or 5% glucose solution 500mL, 3-hour Continuous infusion, Level 0: 175 mg/m2, Level 1: 140 mg/m2, Level 2: 105 mg/m2 (dose reduction in function of toxicity), Day 1 of each cycle, max of 3 cycles; each cycle of 21 days ± 3 days.

DRUG

cisplatin

solution mixed with 0.9% saline 500mL, 30 to 90 min intravenous infusion, Level 0: 75 mg/m2, Level 1: 60 mg/m2, Level 2: 45 mg/m2 (dose reduction in function of toxicity), Day 1 of each cycle, max of 3 cycles; each cycle of 21 days ± 3 days.

Trial Locations (2)

Unknown

Local Insitution, Seoul

Local Institution, Seoul

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY