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Radiosensitization With Celecoxib and Chemoradiation for Head and Neck Cancer (RAD0201)

This study has been completed.
Sponsor:
Collaborators:
Bristol-Myers Squibb
Pharmacia
Information provided by (Responsible Party):
Sharon Spencer, MD,, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00581971
First received: December 20, 2007
Last updated: March 13, 2013
Last verified: March 2013
Results First Received: May 30, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Cancer
Interventions: Drug: celecoxib
Drug: Carboplatin
Drug: Paclitaxel
Radiation: Radiation Therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy 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.

Participant Flow:   Overall Study
    Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy  
STARTED     30  
COMPLETED     30  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy No text entered.

Baseline Measures
    Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy  
Number of Participants  
[units: participants]
  30  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     29  
>=65 years     1  
Age  
[units: years]
Mean ± Standard Deviation
  53.83  ± 8.06  
Gender  
[units: participants]
 
Female     4  
Male     26  
Region of Enrollment  
[units: participants]
 
United States     30  



  Outcome Measures
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1.  Primary:   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 ]

2.  Primary:   Response as Evaluated by Recurrence of Diseases   [ Time Frame: 2 years from end of treatment (Radiation therapy) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Sharon Spencer Professor of Radiation Oncology
Organization: UAB Hospital
phone: 205-934-2762
e-mail: sspencer@uabmc.edu


Publications:
Altorki, N. K., R. S. Keresztes, et al. (2002). "Celecoxib (Celebrex), a selective COX-2 inhibitor, enhances the response to preoperative paclitaxel/carboplatin in early stage non-small cell lung cancer." Proceedings of the American Society of Clinical Oncology Altorki, N. K., R. S. Keresztes, et al. (2002). "Celecoxib (Celebrex), a selective COX-2 inhibitor, enhances the response to preoperative paclitaxel/carboplatin in early stage non-small cell lung cancer." Proceedings of the American Society of Clinical Oncology Abstract 101
Bourhis, J., G. Calais, et al. (1998). "[Chemoradiotherapy of carcinomas of the upper aerodigestive tract]." Cancer Radiother 2(6): 679-88.
Forastiere, A. A. (1994). "Paclitaxel (Taxol) for the treatment of head and neck cancer." Semin Oncol 21(5 Suppl 8): 49-52.
Grizzle, W. E., R. B. Myers, et al. (1998). Immunohistochemical evaluation of biomarkers in prostatic and colorectal neoplasia. John Walker's Methods in Molecular Medicine - Tumor Marker Protocols. M. Hanausek and Z. Walaszek. Totowa, NJ, Humana Press, Inc.: 143-160
Grizzle, W. E., R. B. Myers, et al. (1998). Factors affecting immunohistochemical evaluation of biomarker expression in neoplasia. John Walker's Methods in Molecular Medicine - Tumor Marker Protocols. M. Hanausek and Z. Walaszek. Totowa, NJ, Humana Press, Inc.: 161-180.
Schatz, S. P., L. B. Harrison, et al. (1997). Tumors of the nasal cavity and paranasal sinuses, nasopharynx, oral cavity, and oropharynx. Cancer: 741-801.
Steinauer, K. K., I. Gibbs, et al. (2000). "Radiation induces upregulation of cyclooxygenase-2 (COX-2) protein in PC-3 cells." Int J Radiat Oncol Biol Phys 48(2): 325-8.


Responsible Party: Sharon Spencer, MD,, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00581971     History of Changes
Other Study ID Numbers: F020703003, Link No: 000276825
Study First Received: December 20, 2007
Results First Received: May 30, 2012
Last Updated: March 13, 2013
Health Authority: United States: Institutional Review Board