Status:
COMPLETED
Celecoxib and Erlotinib 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
21+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Celecoxib may stop the growth of cancer by stopping blood flow to the tumor. Erlotinib and celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. C...
Detailed Description
OBJECTIVES: Primary * Determine the biologically active dose of celecoxib administered with erlotinib in patients with stage IIIB or IV non-small cell lung cancer. * Determine the toxicity profile o...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed non-small cell lung cancer (NSCLC)
- Stage IIIB or IV
- Measurable disease
- Progressive disease after at least 2 prior standard chemotherapy regimens OR refused standard chemotherapy
- No active CNS metastases
- PATIENT CHARACTERISTICS:
- Age
- 21 and over
- Performance status
- ECOG 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count at least 1,500/mm\^3
- Platelet count at least 100,000/mm\^3
- Hepatic
- Bilirubin no greater than 1.5 mg/dL
- Transaminases no greater than 2.5 times upper limit of normal (ULN)
- PT and/or PTT no greater than 1.5 times ULN
- Renal
- Creatinine no greater than 2 mg/dL
- Cardiovascular
- No New York Heart Association class III or IV cardiac disease
- No myocardial infarction within the past year
- No symptomatic ventricular arrhythmia
- No symptomatic conduction abnormality
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior gastrointestinal ulceration, bleeding, or perforation
- No hypersensitivity to celecoxib, sulfonamides, aspirin, other NSAIDs, or other reagents used in this study
- No concurrent disease or medical condition that would preclude study treatment or compliance
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- See Disease Characteristics
- More than 4 weeks since prior chemotherapy
- Endocrine therapy
- More than 4 weeks since prior corticosteroids
- No concurrent steroids (including chronic use)
- Concurrent topical steroids allowed
- Radiotherapy
- More than 4 weeks since prior radiotherapy
- Surgery
- Not specified
- Other
- More than 4 weeks since prior non-cytotoxic investigational agents
- More than 3 days since prior nonsteroidal anti-inflammatory drugs (NSAIDs)
- No prior cyclooxygenase-2 (COX-2) inhibitors for metastatic NSCLC
- No prior epidermal growth factor receptor inhibitor for metastatic NSCLC
- No concurrent COX-2 inhibitors
- No concurrent NSAIDs
- No concurrent fluconazole or lithium
Exclusion
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00072072
Start Date
August 1 2003
End Date
January 1 2006
Last Update
September 20 2013
Active Locations (1)
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1
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781