Conditions: Cancer
Keywords: Radiosensitization COX-2 inhibitor Celecoxib Head and Neck Cancer Chemoradiation
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 30
Healthy volunteers: no

Brief summary:
This is a single-institution, open-label, non-randomized phase IB/II trial of celecoxib administered concurrently with carboplatin, paclitaxel, and radiation therapy in patients with locally advanced or recurrent squamous cell carcinoma of the head and neck.

Detailed description:
Treatment for this protocol consists of radiotherapy, 70.2Gy, at 1.8Gy qd, Monday through Friday.Celecoxib 400mg bid is taken during radiotherapy, starting 1 week before radiotherapy. Carboplatin IV, AUC 2.0, weekly for weeks 1 through 7,Paclitaxel 45 mg/m2, weekly for weeks 1 through 7, and Celecoxib 400mg bid, continuing after therapy for two years or until disease progression.

Arms:
arm 1: None

Interventions: intervention 1: celecoxib intervention 2: Carboplatin intervention 3: Paclitaxel intervention 4: Radiation Therapy
Intervention descriptions: intervention 1: 400mg bid starting 1 week before radiotherapy and taken through radiotherapy. intervention 2: IV, AUC 2.0, weekly for weeks 1 through 7 intervention 3: IV 30 mg/m2, weekly for weeks 1 through 7 intervention 4: 70.2Gy, at 1.8Gy qd, Monday through Friday

Protocol document: