Pemetrexed Disodium and Gemcitabine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: gemcitabine HCL; pemetrexed disodium; gemcitabine HCL
Intervention description: 1250 mg/m^2 administered through 250 cc NS (normal saline) IV (intravenous) infusion over 30 minutes at days 1 & 8 of each cycle (21 days) x6 cycles.; 500 mg/m^2 administered through 100 mL NS IV infusion over 10 minutes at day 1 of each cycle.; 1500 mg/m^2 administered through 250 cc NS IV infusion over 30 minutes at days 1 of each cycle (14 days) x9 cycles.
Intervention MeSH terms: Gemcitabine; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent non-small cell lung cancer

Summary:

      RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the
      enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in
      different ways to stop the growth of tumor cells, either by killing the cells or by stopping
      them from dividing. Giving pemetrexed disodium together with gemcitabine may kill more tumor
      cells.

      PURPOSE: This randomized phase II trial is studying two different schedules of pemetrexed
      disodium and gemcitabine to compare how well they work in treating patients with stage IIIB
      or stage IV non-small cell lung cancer.
    

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