Phase II Study of the Combination of ZD1839 (Iressa) and Celecoxib in Patients With Platinum Refractory Non-Small Cell Lung Cance
Inclusion 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