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
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare response rates in patients with stage IIIB or IV non-small cell lung cancer
           treated with two different treatment schedules of pemetrexed disodium and gemcitabine
           hydrochloride.

      Secondary

        -  Compare time-to-event efficacy variables in patients treated with these regimens.

        -  Compare progression-free and overall survival of patients treated with these regimens.

        -  Determine the overall toxicity of these regimens in these patients.

      OUTLINE: This is a multicenter, open-label, randomized study. Patients are stratified
      according to disease stage (IIIB vs IV) and ECOG performance status (0 vs 1). Patients are
      randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive pemetrexed disodium IV over 10 minutes and gemcitabine
           hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up
           to 6 courses in the absence of disease progression or unacceptable toxicity.

        -  Arm II: Patients receive pemetrexed disodium IV over 10 minutes and gemcitabine
           hydrochloride IV over 30 minutes on day 1. Treatment repeats every 14 days for up to 9
           courses in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed periodically for up to 2 years.

      PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
    

Intervention name(s): gemcitabine HCL; pemetrexed disodium; gemcitabine HCL
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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.
Other intervention name(s): GEMZAR; ALIMTA; GEMZAR
Intervention MeSH terms: Gemcitabine; Pemetrexed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent non-small cell lung cancer