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Trial record 1 of 1 for:    10728691 [PUBMED-IDS]
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Radiosensitization With Celecoxib and Chemoradiation for Head and Neck Cancer (RAD0201)

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ClinicalTrials.gov Identifier: NCT00581971
Recruitment Status : Completed
First Posted : December 28, 2007
Results First Posted : April 25, 2013
Last Update Posted : April 25, 2013
Sponsor:
Collaborators:
Bristol-Myers Squibb
Pharmacia
Information provided by (Responsible Party):
Sharon Spencer, MD,, University of Alabama at Birmingham

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cancer
Interventions Drug: celecoxib
Drug: Carboplatin
Drug: Paclitaxel
Radiation: Radiation Therapy
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 30
Completed 30
Not Completed 0
Arm/Group Title Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
29
  96.7%
>=65 years
1
   3.3%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
53.83  (8.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
4
  13.3%
Male
26
  86.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title 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.
Hide Description Particpants experiencing Acute Toxicities > Grade 3
Time Frame 2 years from radiation therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acute Toxicity
Hide Arm/Group Description:
Participants that experienced Grade 3 or higher toxicity factors.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
Hematologic 12
Dermatitis 7
Mucositis/Dysphagia 16
2.Primary Outcome
Title Response as Evaluated by Recurrence of Diseases
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Recurrence
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: Participants
Local Control Only 6
Local Control and Distant Metastasis 2
Distant Metastatsis Only 1
Secondary Primary - Site Unknown 2
Surgical Salvage 3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy
Affected / at Risk (%) # Events
Total   12/30 (40.00%)    
Blood and lymphatic system disorders   
Anemia   1/30 (3.33%)  1
Neutropenia   3/30 (10.00%)  3
Gastrointestinal disorders   
Vomiting   3/30 (10.00%)  3
General disorders   
Fever (in absence of Neutropenia)   1/30 (3.33%)  1
Immune system disorders   
Febrile Neutropenia   2/30 (6.67%)  2
Infections and infestations   
Pneumonia   1/30 (3.33%)  1
Nervous system disorders   
Syncope   1/30 (3.33%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea   1/30 (3.33%)  1
Skin and subcutaneous tissue disorders   
Radiation Dermatitis   1/30 (3.33%)  1
Vascular disorders   
Stroke   1/30 (3.33%)  1
Thrombosis   1/30 (3.33%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy
Affected / at Risk (%) # Events
Total   29/30 (96.67%)    
Blood and lymphatic system disorders   
Neutropenia   10/30 (33.33%)  12
Anemia   2/30 (6.67%)  2
Gastrointestinal disorders   
Mucositis   8/30 (26.67%)  9
Dysphagia   21/30 (70.00%)  24
Esophagitis   3/30 (10.00%)  3
Vomiting   2/30 (6.67%)  2
Nausea   3/30 (10.00%)  3
Metabolism and nutrition disorders   
Dehydration   3/30 (10.00%)  3
Respiratory, thoracic and mediastinal disorders   
Dyspnea   2/30 (6.67%)  2
Skin and subcutaneous tissue disorders   
Radiation Dermatitis   5/30 (16.67%)  7
Indicates events were collected by systematic assessment
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
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
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.
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
First Submitted: December 20, 2007
First Posted: December 28, 2007
Results First Submitted: May 30, 2012
Results First Posted: April 25, 2013
Last Update Posted: April 25, 2013