Celecoxib Treatment for Lung Cancer

This study has been terminated.
(Couldn't accrue patients at the VA and study terminated at the VA but open at UCLA and City of Hope Medical centers. Termination date at the VA is 8/9/2011)
Sponsor:
Collaborators:
University of California, Los Angeles
City of Hope Medical Center
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00108186
First received: April 14, 2005
Last updated: August 10, 2011
Last verified: August 2011

April 14, 2005
August 10, 2011
October 2004
June 2010   (final data collection date for primary outcome measure)
Measure bio-markers; safety measures [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00108186 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Celecoxib Treatment for Lung Cancer
Celecoxib-Mediated Inhibition of T Regulatory Cells in Human Lung Cancer

This proposal evaluates cyclooxygenase 2 (COX-2) inhibition as a means to decrease T regulatory cell activities and thus augment immune responses against lung cancer. The broad goal focuses on understanding how COX-2 expression regulates the malignant phenotype in non small cell lung cancer in an effort to foster an informed approach for the use of COX-2 inhibitors in prevention and therapy for lung cancer.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Non-Small-Cell Lung Carcinoma
Drug: Celecoxib
Eight subjects will be assigned to one of three cohorts. Subjects will receive Celecoxib in escalating doses per cohort, starting with 200mg twice a day by mouth; 400mg twice a day by mouth; and increasing to 600mg twice a day by mouth, for a total of 7 days. Subjects will have blood taken before the start of Celecoxib, and after completion of 7-days of Celecoxib.
1
Celecoxib is an FDA approved drug for other indications such as osteoarthritis. It is not FDA approved for non-small cell lung cancer.
Intervention: Drug: Celecoxib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
24
June 2011
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pathologically confirmed and surgically resectable non small cell lung cancer and subjects must be ineligible for or refuse, neoadjuvant therapy

Exclusion Criteria:

Hypersensitivity to celecoxih or NSAIDs, previous history of GI bleeding or ulceration, chronic or concurrent use of steroids and renal insufficiency

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00108186
ONCA-043-04S
Yes
Dubinett, Steven - Principal Investigator, Department of Veterans Affairs
Department of Veterans Affairs
  • University of California, Los Angeles
  • City of Hope Medical Center
Principal Investigator: Steven Dubinett, MD VA Greater Los Angeles Healthcare System, West LA
Department of Veterans Affairs
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP