Clinical trial NCT00265785 (phase 2, status: terminated)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: pemetrexed
SMILES: [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]
Reason stopped: 
    closed due to poor accrual
  
Eligibility 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