Pemetrexed Disodium and Gemcitabine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

Stage IIIB (with controlled pleural effusion) OR stage IV disease
At least 1 measurable lesion whose longest diameter is ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
No medically significant third-space fluid collection (e.g., ascites or pleural effusions) that cannot be controlled by drainage or other procedures

No documented brain metastases unless all of the following criteria are met:

Successful local therapy has been completed
At least 2 weeks since prior corticosteroids
Brain imaging required for symptomatic patients only (to rule out brain metastases)
Concurrent enrollment in clinical trial MCCRC-RC0527 required

PATIENT CHARACTERISTICS:

Life expectancy ≥ 12 weeks
ECOG performance status 0-1
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 9.0 g/dL
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
Alkaline phosphatase ≤ 3 times ULN
AST and ALT ≤ 3 times ULN (5 times ULN for liver involvement)
Creatinine clearance ≥ 45 mL/min
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Able to take folic acid, cyanocobalamin (vitamin B12) supplementation, or dexamethasone and corticosteroids
Able to interrupt intake of aspirin and nonsteroidal anti-inflammatory agents for a total of 5 days

No severe and/or uncontrolled medical conditions, including any of the following:

Hypertension, labile hypertension, or history of poor compliance with antihypertensive medication
Angina pectoris
Congestive heart failure within the past 3 months, unless ejection fraction > 40%
Myocardial infarction within the past 6 months
Cardiac arrhythmia
Diabetes
Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
New York Heart Association class III or IV heart disease
Clinically significant infection
No other serious medical condition or illness that would preclude study participation
No peripheral neuropathy ≥ grade 2
No other malignancy within the past 5 years except nonmelanomatous skin cancer, carcinoma in situ of the cervix, or low-grade (Gleason score ≤ 6) localized prostate cancer
No significant weight loss (≥ 10%) within the past 6 weeks
No investigator site personnel directly affiliated with the study, or immediate family (i.e., spouse, parent, child, or sibling, whether biological or legally adopted)

No employees of Eli Lilly (i.e., employees, temporary contract workers, or designees responsible for conducting the study)

Immediate family of Eli Lilly employees may participate in Eli Lilly-sponsored clinical trials, but are not permitted to participate at an Eli Lilly facility

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
At least 2 weeks since prior corticosteroids
At least 4 weeks since prior radiation therapy involving > 25% of the bone marrow and recovered
At least 30 days since prior investigational therapy
No prior radiation therapy to the whole pelvis
No prior systemic chemotherapy for advanced non-small cell lung cancer
No prior pemetrexed disodium and/or gemcitabine hydrochloride
No prior or concurrent sorafenib tosylate and/or temsirolimus
No concurrent Hypericum perforatum (St. John's wort)
No other concurrent antitumor therapy
No concurrent agents that stimulate thrombopoiesis
Concurrent palliative radiation therapy allowed
Concurrent corticosteroids allowed for adrenal insufficiency or severe nausea and vomiting