Clinical trial NCT00268489 (phase 2, status: completed)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: pemetrexed disodium
SMILES: [H][C@@](CCC(O)=O)(NC(=O)C1=CC=C(CCC2=CNC3=C2C(O)=NC(=N)N3)C=C1)C(O)=O
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically diagnosed stage IIIB or IV non-small cell lung cancer

               -  Stage IIIB patients must have pleural effusion

                    -  No symptomatic serosal effusion (grade 2 dyspnea) that is not amenable to
                       drainage

               -  Mixed histology allowed if all components consistent with non-small cell lung
                  cancer

               -  Tumors with squamous cell histology feature are allowed

          -  Must have measurable disease with at least one lesion with a longest diameter
             accurately measured as ≥ 2.0 cm with conventional techniques or as ≥ 1.0 cm with
             spiral CT

               -  Large ( > 4 cm) centrally located lesions or large lesions in close proximity to
                  major blood vessels should receive palliative radiation

                    -  The irradiated lesion should not be a target lesion

          -  Previously treated with one chemotherapy regimen in the neoadjuvant, adjuvant, or
             advanced disease setting

          -  No symptomatic, untreated, or uncontrolled CNS metastases

               -  CNS metastases treated with prior whole brain radiotherapy allowed

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Life expectancy ≥ 12 weeks

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/ mm^3

          -  Hemoglobin ≥ 9 g/dL

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN) or direct bilirubin normal

          -  AST and ALT ≤ 3 times ULN (5 times ULN if liver has tumor involvement)

          -  Creatinine clearance ≥ 45 mL/min

          -  Urine protein:creatinine ratio < 1.0

          -  Pregnant or nursing women are ineligible

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 3 months after study
             participation

          -  No seizure disorder

          -  No clinically significant infection

          -  No other second primary malignancy within the past 5 years except carcinoma in situ of
             the cervix, non-melanomatous skin cancer, or low-grade (Gleason score ≤ 6) localized
             prostate cancer

          -  No hypertension or labile hypertension

          -  No history of poor compliance with antihypertensive medications

          -  No angina pectoris

          -  No congestive heart failure within the past 3 months unless ejection fraction > 40%

          -  No myocardial infarction within the past 6 months

          -  No cardiac arrhythmia

          -  No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the
             lung

          -  No active or recent history of hemoptysis

               -  Hemoptysis resolved > 2 weeks ago with measures such as palliative radiation
                  therapy (i.e., 3,000 cGy over 10 fractions), arteriographic embolization, or
                  endobronchial interventions (e.g., photodynamic therapy or brachytherapy) is
                  acceptable

          -  No diabetes

          -  No prior serious, non-healing wounds, ulcers, or bone fractures

          -  No history of stroke within the past 6 months

          -  No history of abdominal fistula or gastrointestinal perforation

          -  No intra-abdominal abscess within the past 6 months

          -  Not at greater than average risk of bleeding

          -  No significant traumatic injury within the past 4 weeks

        PRIOR CONCURRENT THERAPY:

          -  No aspirin at doses ≥ 1.3 grams per day within 10 days prior to or 10 days after
             pemetrexed disodium treatment

          -  No chemotherapy within the past 3 weeks (6 weeks for mitomycin C or nitrosoureas)

          -  No immunotherapy or biologic therapy within the past 2 weeks

          -  No full field radiation therapy within the past 4 weeks or limited field radiation
             therapy within the past 2 weeks

               -  The site of previous radiotherapy should have evidence of progressive disease if
                  it is the only site of disease

          -  No prior post pelvic radiation

          -  No prior use of pemetrexed disodium

          -  No prior radiation to > 25% of the marrow cavity

          -  No major surgery (i.e., laparotomy) or open biopsy within the past 4 weeks

          -  No minor surgery within the past 2 weeks except insertion of a vascular access device

          -  No concurrent major surgery

          -  No other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, or any ancillary
             therapy considered investigational within the past 4 weeks

          -  No concurrent use of Hypericum perforatum (St. John's wort)

          -  No concurrent anticoagulant use

               -  Low-dose warfarin or heparin for deep venous thrombosis prophylaxis allowed