Paclitaxel, Carboplatin and Cetuximab (PCC) With Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) in Previously Untreated Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

128

Participants

Timeline

Start Date

July 9, 2010

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Head and Neck Squamous Cell Carcinoma
Interventions
DRUG

Paclitaxel

135 mg/m\^2 weekly, Weeks 1 - 6

DRUG

Carboplatin

AUC of 2 weekly, Weeks 1 - 6

DRUG

Cetuximab

"PCC Arm: 400 mg/m\^2 by vein over about 1-2 hours on Day 1; 250 mg/m\^2 weeks 2 - 6.~C-TPF Arm: 250 mg/m2 weeks 2, 4, 5, 7 and 8."

DRUG

Docetaxel

75 mg/m\^2 by vein over 1 hour on Day 1 of each 21 day cycle for 3 cycles of induction therapy

DRUG

Cisplatin

100 mg/m\^2 by vein over 1-3 hours on Day 1 of each 21 day cycle for 3 cycles of induction therapy

DRUG

Fluorouracil

700 mg/m\^2 continuous infusion Days 1-4 on Day 1 of each 21 day cycle for 3 cycles of induction therapy

RADIATION

Radiotherapy (RT)

Radiation about 2-4 weeks after induction therapy, Monday through Friday for about 7 weeks, or as recommended by the treating radiologist.

OTHER

Chemotherapy

PCC group receives 6 and C-TPF group receives 3 chemotherapy treatment cycles. If receiving radiation + chemotherapy, weekly Cisplatin 40 mg/m\^2 by vein over 1-3 hours or Carboplatin AUC 2 by vein over 1 hour beginning 2 to 3 weeks after conclusion of induction program.

Trial Locations (2)

20115

Dana Farber Cancer Institute, Boston

77030

University of Texas MD Anderson Cancer Center, Houston

All Listed Sponsors
collaborator

Dana-Farber Cancer Institute

OTHER

lead

M.D. Anderson Cancer Center

OTHER