Phase II Study to Evaluate the Efficacy and Toxicity of Multimodality Treatment With Induction Taxotere/Cisplatin?5-FU (TPF) Chemotherapy Followed by Concomitant Cetuximab and Radiation Therapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)

NCT00721513 Phase 2 COMPLETED Results posted

RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with cetuximab and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel, cisplatin, and fluorouracil together with cetuximab and radiation therapy works in treating patients with locally advanced head and neck cancer.

Details

Lead sponsor	Wake Forest University Health Sciences
Phase	Phase 2
Status	COMPLETED
Enrolment	20
Start date	2008-09
Completion	2014-08

Conditions

• Head and Neck Cancer

Interventions

• cetuximab
• cisplatin
• docetaxel
• fluorouracil
• computed tomography
• positron emission tomography
• quality-of-life assessment
• 3-dimensional conformal radiation therapy
• intensity-modulated radiation therapy

Primary outcomes

• Progression-free Survival — up to 2 years

Countries

United States