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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
400mg bid starting 1 week before radiotherapy and taken through radiotherapy.
IV, AUC 2.0, weekly for weeks 1 through 7
IV 30 mg/m2, weekly for weeks 1 through 7
University of Alabama at Birmingham
Birmingham, Alabama, United States
Toxicity of Celecoxib With Concurrent Weekly Chemotherapy and Radiotherapy in the Treatment of Locally Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck.
Particpants experiencing Acute Toxicities \> Grade 3
Time frame: 2 years from radiation therapy
Response as Evaluated by Recurrence of Diseases
Evaluate the response to concurrent celecoxib, carboplatin, paclitaxel, and radiotherapy in the treatment of locally advanced SSC of the head and neck. Response is determined by local control only, local and distant metastasis, distant metastasis only, second primary, and surgical salvage.
Time frame: 2 years from end of treatment (Radiation therapy)
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70.2Gy, at 1.8Gy qd, Monday through Friday