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