S0526: Pemetrexed Disodium in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Inclusion Criteria

• •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