Clinical Research Directory
Browse clinical research sites, groups, and studies.
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
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
Conditions
Interventions
Paclitaxel
135 mg/m\^2 weekly, Weeks 1 - 6
Carboplatin
AUC of 2 weekly, Weeks 1 - 6
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.
Docetaxel
75 mg/m\^2 by vein over 1 hour on Day 1 of each 21 day cycle for 3 cycles of induction therapy
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
Fluorouracil
700 mg/m\^2 continuous infusion Days 1-4 on Day 1 of each 21 day cycle for 3 cycles of induction therapy
Radiotherapy (RT)
Radiation about 2-4 weeks after induction therapy, Monday through Friday for about 7 weeks, or as recommended by the treating radiologist.
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