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ACTIVE NOT RECRUITING
NCT01154920
PHASE2

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

Sponsor: M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

The goal of this clinical research study is to learn which chemotherapy combination is more effective in treating locally advanced head and neck squamous cell carcinoma. The side effects of these combinations will also be studied.

Official title: Randomized Phase II Trial Contrasting Weekly 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

128

Start Date

2010-07-09

Completion Date

2027-12-31

Last Updated

2025-12-17

Healthy Volunteers

No

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.

Locations (2)

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States