Status:
COMPLETED
Celecoxib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also stimulate the immune system in different ways and stop tumor cells from grow...
Detailed Description
OBJECTIVES: Primary * Determine the optimal biologic dose (OBD) of celecoxib that is necessary to decrease peripheral blood lymphocyte CD4+ and CD25+ T-lymphocyte regulatory cells in patients with s...
Eligibility Criteria
Inclusion
- Histologically confirmed non-small cell lung cancer
- Stage IIIB or IV disease
- Radiographically measurable disease
- 18 and over
- Performance status: ECOG 0-2
- Renal: Creatinine ≤ 2 mg/dL
- Negative pregnancy test
- Fertile patients must use effective contraception
- More than 4 weeks since prior chemotherapy
- Endocrine therapy: More than 4 weeks since prior corticosteroids; No concurrent corticosteroids, including chronic corticosteroids, except for medically-indicated topical steroids
- Radiotherapy: More than 4 weeks since prior radiotherapy
- More than 4 weeks since other prior anticancer therapy
- More than 4 weeks since prior non-cytotoxic investigational agents
- At least 72 hours since prior nonsteroidal anti-inflammatory drugs (NSAIDs)
Exclusion
- pregnant or nursing
- comorbid disease, psychiatric condition, chronic medical condition, or laboratory abnormality that would preclude study treatment or compliance with study requirements
- hypersensitivity to celecoxib, sulfonamides, aspirin, other NSAIDs, or any study reagent
- history of gastrointestinal ulceration, bleeding, or perforation
- other concurrent cyclooxygenase-2 or -3 inhibitors
- other concurrent NSAIDs
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00104767
Start Date
January 1 2009
End Date
October 1 2015
Last Update
October 2 2015
Active Locations (1)
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1
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781