• Overall survival [ Designated as safety issue: No ]
  

• Progression-free survival [ Designated as safety issue: No ]
  
• Response rate (confirmed and unconfirmed, partial and complete) as assessed by RECIST criteria and computer assisted image analysis [ Designated as safety issue: No ]
  
• Toxicity [ Designated as safety issue: Yes ]
  

OBJECTIVES:

Primary

• Determine the overall survival of patients with selected stage IIIB or IV bronchoalveolar carcinoma treated with pemetrexed disodium.

Secondary

• Determine the progression-free survival of patients treated with this drug.
• Determine the response rate (confirmed and unconfirmed, partial and complete) in these patients with measurable disease treated with this drug using standard RECIST criteria and computer assisted image analysis.
• Evaluate frequency and severity of toxicities in patients treated with this drug.

OUTLINE: Patients are stratified according to prior treatment with gefitinib or erlotinib (yes vs no).

Patients receive pemetrexed disodium IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 3 years.

PROJECTED ACCRUAL: A total of 99 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically confirmed bronchoalveolar carcinoma (BAC) or BAC variants such as adenocarcinoma with BAC features or BAC with invasive adenocarcinoma

  • Cytology specimens, such as bronchial brushings, washings, or fine needle aspiration specimens alone are not acceptable for diagnosis
• Stage IV disease OR selected stage IIIB (T4 [secondary to malignant pleural effusion only], any N, M0) disease
• Incompletely resected or unresectable disease
• Pleural effusions, ascites, or laboratory parameters cannot be only evidence of disease
• Measurable disease or nonmeasurable disease documented by CT scan
• No known brain metastases

PATIENT CHARACTERISTICS:

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• SGOT and SGPT ≤ 2.5 times ULN ( ≤ 5 times ULN if due to liver metastases)
• Alkaline phosphatase ≤ 2.5 times ULN ( ≤ 5 times ULN if due to bone metastases)
• Creatinine clearance ≥ 45 mL/min OR creatinine ≤ 1.5 times ULN
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 75,000/mm³
• Zubrod 0-2
• No history of allergic reaction to compounds of similar chemical or biological composition as pemetrexed disodium
• Must provide smoking history
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
• Not pregnant or nursing
• Fertile patients must use effective contraception
• Able to swallow pills

PRIOR CONCURRENT THERAPY:

• No more than 2 prior systemic therapies (including epidermal growth factor receptor inhibitor)
• At least 28 days since prior systemic therapy
• Patients treated with prior erlotinib or gefitinib must have shown progression since treatment
• No prior pemetrexed disodium

• At least 28 days since prior radiotherapy and recovered

  • Must have measurable or nonmeasurable disease outside previously irradiated area or a new lesion within previously irradiated area
• At least 14 days since prior palliative radiotherapy and recovered
• At least 28 days since prior thoracic or major surgery and recovered
• No concurrent surgery
• No other concurrent therapy (hormonal, biologic or radiotherapy) for this disease
• No concurrent antiretroviral therapy
• Patients should discontinue non-steroidal anti-inflammatory drugs (NSAIDs) with longer half lives (etodolac, ketordac, sulindac, naproxen, naproxen sodium, oxaprozin, nabumetone, diflunisal, salsalate, celecoxib, rofecoxib, valdecoxib, meloxicam, piroxicam) at least 5 days before and for 2 days following pemetrexed treatment