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Radiosensitization With Celecoxib and Chemoradiation for Head and Neck Cancer

NCT00581971 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-04-25

Study results available
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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.

Conditions

Interventions

DRUG

celecoxib

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

DRUG

Carboplatin

IV, AUC 2.0, weekly for weeks 1 through 7

DRUG

Paclitaxel

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

RADIATION

Radiation Therapy

70.2Gy, at 1.8Gy qd, Monday through Friday

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Pharmacia

    collaborator INDUSTRY

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Sharon Spencer, M.D. · University of Alabama at Birmingham

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-09-30
Primary Completion
2007-12-31
Completion
2012-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00581971 on ClinicalTrials.gov