Neoplasms

All Conditions

Head and Neck Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Celecoxib

Cyclooxygenase 2 Inhibitors

Tubulin Modulators

Antimitotic Agents

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

400mg bid starting 1 week before radiotherapy and taken through radiotherapy.

celecoxib

IV, AUC 2.0, weekly for weeks 1 through 7

IV 30 mg/m2, weekly for weeks 1 through 7

70.2Gy, at 1.8Gy qd, Monday through Friday

Radiation Therapy

Sharon Spencer, M.D.

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.

Radiosensitization With Celecoxib and Chemoradiation for Head and Neck Cancer

Radiosensitization With a COX-2 Inhibitor (Celecoxib), With Chemoradiation for Cancer of the Head and Neck

Particpants experiencing Acute Toxicities \> Grade 3

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.

Bristol-Myers Squibb

Pharmacia

University of Alabama at Birmingham

Professor - Radiation Oncology

Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Dr. Sharon Spencer Professor of Radiation Oncology

Hematologic

Dermatitis

Mucositis/Dysphagia

Participants that experienced Grade 3 or higher toxicity factors.

Acute Toxicity

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.

Local Control Only

Local Control and Distant Metastasis

Distant Metastatsis Only

Secondary Primary - Site Unknown

Surgical Salvage

Recurrence

Response as Evaluated by Recurrence of Diseases

Patients with locally advanced head and neck cancer will be treated with weekly carboplatin, paclitaxel, and concurrent radiotherapy. Radiotherapy will be delivered at 1.8 Gy every day, to a maximum dose of 70.2 Gy. Carboplatin will be dosed at AUC=2.0, while paclitaxel will be dosed at 30mg/m2. Celecoxib will be delivered at 400mg twice daily, starting 1 week prior to the onset of radiotherapy to establish constant blood levels.

Overall Study

Spots Global Cancer Trial Database for Radiosensitization With Celecoxib and Chemoradiation for Head and Neck Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial