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Randomized Phase II Study of Docetaxel and Gemcitabine for Stage IIIB/IV Non-Small Cell Lung Cancer (NCT00003762)

National Cancer Institute (NCI)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of docetaxel plus gemcitabine in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
  • Drug: docetaxel
    • Drug: gemcitabine hydrochloride
      Ages eligible for Study
      18 Years and older
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      OBJECTIVES: I. Evaluate the response rate of patients with stage IIIB or IV nonsmall cell lung cancer to different schedules of docetaxel and gemcitabine therapy. II. Evaluate the toxicity of this treatment in these patients. III. Describe the quality of life parameters of patients receiving this combination therapy. IV. Determine the survival rate of these patients.

      OUTLINE: This is a randomized study. Patients are stratified by disease (stage IIIB vs stage IV) and performance status (0 vs 1). Patients are randomized to one of two treatment arms (Arm I now closed). Arm I: Patients receive docetaxel IV over 1 hour on day 1 followed by gemcitabine IV over 30 minutes on days 1, 8, and 15. (closed as of 8/31/1999) Arm II: Patients receive docetaxel IV over 1 hour and gemcitabine IV over 30 minutes on days 1 and 15. Arm III: Patients receive docetaxel IV on day 1 and gemcitabine IV on days 1, 8, and 15. Patients continue treatment every 28 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients with either stable disease or complete/partial response who discontinue treatment after 4-6 courses may be eligible for NCCTG-97-24-51. Quality of life is assessed before treatment and before each course of therapy. Patients are followed every 3 months for 1 year, then every 3 months for 5 years.

      PROJECTED ACCRUAL: A total of 19-53 patients will be accrued for this study within 6-18 months.

      17 locations

      United States (17)
      • CCOP - Scottsdale Oncology Program
        Scottsdale, Arizona, United States, 85259-5404
      • CCOP - Carle Cancer Center
        Urbana, Illinois, United States, 61801
      • CCOP - Cedar Rapids Oncology Project
        Cedar Rapids, Iowa, United States, 52403-1206
      • CCOP - Iowa Oncology Research Association
        Des Moines, Iowa, United States, 50309-1016
      • Siouxland Hematology-Oncology
        Sioux City, Iowa, United States, 51101-1733
      • CCOP - Wichita
        Wichita, Kansas, United States, 67214-3882
      • CCOP - Ann Arbor Regional
        Ann Arbor, Michigan, United States, 48106
      • CCOP - Duluth
        Duluth, Minnesota, United States, 55805
      • Mayo Clinic Cancer Center
        Rochester, Minnesota, United States, 55905
      • CentraCare Clinic
        Saint Cloud, Minnesota, United States, 56303
      • CCOP - Metro-Minnesota
        Saint Louis Park, Minnesota, United States, 55416
      • CCOP - Missouri Valley Cancer Consortium
        Omaha, Nebraska, United States, 68131
      • Quain & Ramstad Clinic, P.C.
        Bismarck, North Dakota, United States, 58501
      • CCOP - Merit Care Hospital
        Fargo, North Dakota, United States, 58122
      • Altru Health Systems
        Grand Forks, North Dakota, United States, 58201
      • CCOP - Geisinger Clinical and Medical Center
        Danville, Pennsylvania, United States, 17822-2001
      • Rapid City Regional Hospital
        Rapid City, South Dakota, United States, 57709
      Status:
      completed
      Type:
      Interventional
      Phase:
      Start:
      31 January, 1999
      Updated:
      11 July, 2016
      Participants:
      106
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