Clinical trial NCT00407550 (phase 2, status: completed)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: gemcitabine hcl, pemetrexed disodium, gemcitabine hcl
SMILES: NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F, [H][C@@](CCC(O)=O)(NC(=O)C1=CC=C(CCC2=CNC3=C2C(O)=NC(=N)N3)C=C1)C(O)=O, NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

               -  Stage IIIB (with controlled pleural effusion) OR stage IV disease

          -  At least 1 measurable lesion whose longest diameter is ≥ 20 mm by conventional
             techniques OR ≥ 10 mm by spiral CT scan

          -  No medically significant third-space fluid collection (e.g., ascites or pleural
             effusions) that cannot be controlled by drainage or other procedures

          -  No documented brain metastases unless all of the following criteria are met:

               -  Successful local therapy has been completed

               -  At least 2 weeks since prior corticosteroids

               -  Brain imaging required for symptomatic patients only (to rule out brain
                  metastases)

          -  Concurrent enrollment in clinical trial MCCRC-RC0527 required

        PATIENT CHARACTERISTICS:

          -  Life expectancy ≥ 12 weeks

          -  ECOG performance status 0-1

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Hemoglobin ≥ 9.0 g/dL

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

          -  Alkaline phosphatase ≤ 3 times ULN

          -  AST and ALT ≤ 3 times ULN (5 times ULN for liver involvement)

          -  Creatinine clearance ≥ 45 mL/min

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Able to take folic acid, cyanocobalamin (vitamin B12) supplementation, or
             dexamethasone and corticosteroids

          -  Able to interrupt intake of aspirin and nonsteroidal anti-inflammatory agents for a
             total of 5 days

          -  No severe and/or uncontrolled medical conditions, including any of the following:

               -  Hypertension, labile hypertension, or history of poor compliance with
                  antihypertensive medication

               -  Angina pectoris

               -  Congestive heart failure within the past 3 months, unless ejection fraction > 40%

               -  Myocardial infarction within the past 6 months

               -  Cardiac arrhythmia

               -  Diabetes

               -  Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the
                  lung

               -  New York Heart Association class III or IV heart disease

               -  Clinically significant infection

          -  No other serious medical condition or illness that would preclude study participation

          -  No peripheral neuropathy ≥ grade 2

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

          -  No significant weight loss (≥ 10%) within the past 6 weeks

          -  No investigator site personnel directly affiliated with the study, or immediate family
             (i.e., spouse, parent, child, or sibling, whether biological or legally adopted)

          -  No employees of Eli Lilly (i.e., employees, temporary contract workers, or designees
             responsible for conducting the study)

               -  Immediate family of Eli Lilly employees may participate in Eli Lilly-sponsored
                  clinical trials, but are not permitted to participate at an Eli Lilly facility

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  At least 2 weeks since prior corticosteroids

          -  At least 4 weeks since prior radiation therapy involving > 25% of the bone marrow and
             recovered

          -  At least 30 days since prior investigational therapy

          -  No prior radiation therapy to the whole pelvis

          -  No prior systemic chemotherapy for advanced non-small cell lung cancer

          -  No prior pemetrexed disodium and/or gemcitabine hydrochloride

          -  No prior or concurrent sorafenib tosylate and/or temsirolimus

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

          -  No other concurrent antitumor therapy

          -  No concurrent agents that stimulate thrombopoiesis

          -  Concurrent palliative radiation therapy allowed

          -  Concurrent corticosteroids allowed for adrenal insufficiency or severe nausea and
             vomiting