Radiosensitization With Celecoxib and Chemoradiation for Head and Neck Cancer (RAD0201)
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.
Radiation: Radiation Therapy
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Radiosensitization With a COX-2 Inhibitor (Celecoxib), With Chemoradiation for Cancer of the Head and Neck|
- 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. [ Time Frame: 2 years from radiation therapy ] [ Designated as safety issue: Yes ]Particpants experiencing Acute Toxicities > Grade 3
- Response as Evaluated by Recurrence of Diseases [ Time Frame: 2 years from end of treatment (Radiation therapy) ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||September 2002|
|Study Completion Date:||March 2012|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
|Experimental: Celecoxib+Carboplatin/Paclitaxel+Radiation Therapy||
400mg bid starting 1 week before radiotherapy and taken through radiotherapy.
Other Name: CelebrexDrug: Carboplatin
IV, AUC 2.0, weekly for weeks 1 through 7
Other Name: ParaplatinDrug: Paclitaxel
IV 30 mg/m2, weekly for weeks 1 through 7
Other Name: TaxolRadiation: Radiation Therapy
70.2Gy, at 1.8Gy qd, Monday through Friday
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.
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35249|
|Principal Investigator:||Sharon Spencer, M.D.||University of Alabama at Birmingham|