Lung Cancer Clinical Trial
Gefitinib and Celecoxib in Treating Patients With Refractory Non-Small Cell Lung Cancer
Summary
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Celecoxib may slow the growth of cancer by stopping blood flow to the tumor. Combining gefitinib with celecoxib may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining gefitinib with celecoxib in treating patients who have non-small cell lung cancer that is refractory to platinum-based chemotherapy (such as cisplatin or carboplatin).
Full Description
OBJECTIVES:
Primary
Determine the response rate in patients with platinum-refractory non-small cell lung cancer treated with gefitinib and celecoxib.
Secondary
Determine the progression-free and overall survival of patients treated with this regimen.
Determine the toxicity of this regimen in these patients.
OUTLINE: Patients receive oral gefitinib once daily and oral celecoxib twice daily on days 1-28. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed for up to 6 weeks.
PROJECTED ACCRUAL: A total of 18-27 patients will be accrued for this study within 22 months.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
Progression of disease during platinum-based (cisplatin or carboplatin) chemotherapy or within 3 months of completing chemotherapy
Treatment with other agents since prior platinum-based chemotherapy allowed
Measurable disease
Target lesions within a prior radiation field must have documented evidence of progression at least 8 weeks after the completion of radiotherapy
No active brain or leptomeningeal metastases
Treated brain metastases allowed at least 4 weeks after the completion of appropriate therapy
PATIENT CHARACTERISTICS:
Age
18 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
Hemoglobin at least 8 g/dL
Hepatic
Bilirubin no greater than upper limit of normal (ULN)
AST/ALT no greater than 2.5 times ULN (if alkaline phosphatase is no greater than ULN)
Alkaline phosphatase no greater than 5 times ULN (if AST and ALT are greater than ULN)
No history of chronic hepatitis
Renal
Creatinine no greater than 1.5 times ULN
Cardiovascular
No active thromboembolic event within the past 4 weeks
No uncontrolled congestive heart failure
No uncontrolled angina
No myocardial infarction and/or stroke within the past 6 months
Pulmonary
No evidence of clinically active interstitial lung disease
Gastrointestinal
No history of gastrointestinal bleeding within the past 6 months
No history of peptic ulcer disease
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Must weigh at least 110 pounds (50 kg)
HIV negative
No allergy to sulfonamides
No allergy to any NSAID, including celecoxib
No known severe hypersensitivity to gefitinib or any of its excipients
No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
No history of dementia, active psychiatric disorder, or any other condition that would preclude study compliance
No other concurrent serious medical condition
PRIOR CONCURRENT THERAPY:
Biologic therapy
No prior epidermal growth factor receptor inhibitor
No concurrent biologic therapy
Chemotherapy
See Disease Characteristics
More than 2 weeks since prior chemotherapy
Endocrine therapy
Not specified
Radiotherapy
Recovered from prior radiotherapy
Surgery
Recovered from prior surgery
Other
Recovered from prior therapy
More than 2 weeks since prior investigational therapy
More than 1 week since prior fluconazole
More than 30 days since prior participation in another investigational agent clinical trial
More than 30 days since prior chronic nonsteroidal anti-inflammatory drugs (NSAIDs), including celecoxib or rofecoxib
No prior gefitinib
No prior cyclooxygenase-2 (COX-2) inhibitor or another clinical trial for NSCLC
No other concurrent NSAIDs
Concurrent aspirin allowed (not to exceed 325 mg/day)
No other concurrent COX-2 inhibitors
No concurrent lithium
No concurrent fluconazole
No concurrent use of any of the following:
Phenytoin
Carbamazepine
Barbiturates
Rifampin
Phenobarbital
Hypericum perforatum
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There is 1 Location for this study
Detroit Michigan, 48201, United States
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