Lung Cancer Clinical Trial
Celecoxib and Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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. Combining celecoxib with erlotinib may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib when given together with erlotinib in treating patients with stage IIIB or stage IV non-small cell lung cancer.
Full 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 of this regimen in these patients.
Secondary
Determine the clinical activity of this regimen, in terms of reduction in tumor burden, in these patients.
Correlate biological endpoints with cyclooxygenase-2 and epidermal growth factor receptor inhibition in patients treated with this regimen.
OUTLINE: This is a nonrandomized, dose-escalation study of celecoxib.
Patients receive oral erlotinib once daily and oral celecoxib twice daily on days 1-28. Treatment repeats every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may continue treatment beyond 2 courses at the investigator's discretion.
Cohorts of 3-6 patients receive escalating doses of celecoxib until the maximum tolerated dose (MTD) and biologically active dose (BAD) are determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT). The BAD is defined as the maximum decrease in the level of PGE_2 where no DLT occurs.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 21-27 patients will be accrued for this study.
Eligibility Criteria
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
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There is 1 Location for this study
Los Angeles California, 90095, United States
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