S0526: Pemetrexed Disodium in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: pemetrexed
Intervention description: Pemetrexed 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: bronchoalveolar cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent non-small cell lung cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to
      stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the
      enzymes needed for cell growth.

      PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating
      patients with stage III or stage IV non-small cell lung cancer.
    

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