Celecoxib Treatment for Lung Cancer

NCT00108186 | Withdrawn Phase 1 DMC

• 1 other identifier: ONCA-043-04S
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-Small-Cell Lung Carcinoma

Keywords

cyclooxygenase 2; lung cancer; lymphocytes; non small cell; therapeutics

Outcome Measures

Primary Outcomes (1)

• Measure bio-markers; safety measures

  2 years

Study Arms (1)

Arm 1

OTHER

Celecoxib is an FDA approved drug for other indications such as osteoarthritis. It is not FDA approved for non-small cell lung cancer.

Drug: Celecoxib

Interventions

Celecoxib DRUG

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.

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead
• University of California, Los Angeles: collaborator
• City of Hope Medical Center: collaborator

Study Sites (1)

VA Greater Los Angeles Healthcare System, West LA

West Los Angeles, California, 90073, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Steven Dubinett, MD

  VA Greater Los Angeles Healthcare System, West LA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2005
• First Posted: April 15, 2005
• Study Start: October 1, 2004
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2011
• Last Updated: October 29, 2014

Record last verified: 2014-10

Locations

US (1)