Pemetrexed Disodium Plus Gemcitabine in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer
• •* Stage IIIB disease that is ineligible for combined modality therapy OR
• •* Stage IV disease
• •Measurable disease
• •No clinically detectable (by physical exam) third-space fluid collection (e.g., ascites or pleural effusions) that cannot be controlled by drainage or other procedures
• •No brain metastases (even if treated)
• •PATIENT CHARACTERISTICS:
• •Age:
• •18 and over
• •Performance status:
• •ECOG 0-1
• •Life expectancy:
• •At least 12 weeks
• •Hematopoietic:
• •Absolute neutrophil count at least 1,500/mm\^3
• •Platelet count at least 100,000/mm\^3
• •Hemoglobin at least 9 g/dL
• •Hepatic:
• •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• •AST and ALT no greater than 3 times ULN (5 times ULN if liver metastases present)
• •Alkaline phosphatase no greater than 3 times ULN (5 times ULN if liver metastases present)
• •Renal:
• •Creatinine clearance at least 45 mL/min
• •Other:
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •Able to take folic acid or cyanocobalamin (vitamin B12) supplementation
• •No uncontrolled infection
• •No concurrent chronic debilitating disease
• •No weight loss of 10% or more within the past 6 weeks
• •No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinoma
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •No prior biologic or genetic therapy for lung cancer
• •No concurrent immunomodulating agents
• •Chemotherapy:
• •No prior chemotherapy for lung cancer
• •Endocrine therapy:
• •Not specified
• •Radiotherapy:
• •At least 4 weeks since prior radiotherapy to a different site and recovered
• •No prior radiotherapy to 25% or more of bone marrow
• •No prior radiotherapy to whole pelvis
• •No prior radiotherapy for primary disease
• •No concurrent radiotherapy
• •Surgery:
• •More than 4 weeks since prior major surgery
• •Other:
• •No aspirin or nonsteroidal anti-inflammatory agents 2 days before, during, and for 2 days after pemetrexed disodium administration (5 days for long-acting agents such as piroxicam, naproxen, diflunisal, or nabumetone)
• •No other concurrent cytostatic or cytotoxic therapy