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An Open Label, Multicenter, Randomized, Phase III Comparator Study of Oral Topotecan Versus Intravenous Topotecan for Second Line Therapy in Patients With Small Cell Lung Cancer Who Have Relapsed Greater Than or Equal to 90 Days After Completion of First Line Therapy (NCT00003917)

Smith Kline Beecham
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if topotecan is more effective given by infusion or by mouth. PURPOSE: Randomized phase III trial to compare the effectiveness of topotecan given by infusion with that of topotecan given by mouth in treating patients who have small cell lung cancer that has relapsed following previous therapy.
  • Drug: topotecan hydrochloride
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    OBJECTIVES: I. Compare the response rate, response duration, time to response, time to progression, and survival of patients with relapsed limited or extensive stage small cell lung cancer treated with oral vs intravenous topotecan. II. Compare the qualitative and quantitative toxicities of these treatment regimens in this patient population. III. Compare the quality of life in these patients.

    OUTLINE: This is randomized, multicenter study. Patients are stratified according to gender, liver metastases (yes vs no), and duration of response to prior chemotherapy (6 months or less vs greater than 6 months). Patients are randomized to one of two treatment arms. Arm I: Patients receive topotecan IV over 30 minutes on days 1-5. Arm II: Patients receive topotecan orally on days 1-5. Treatment repeats every 3 weeks in the absence of unacceptable toxicity. Patients experiencing complete or partial response continue until progression or for at least 2 courses past maximal response. Patients with stable disease should receive at least 4 courses. Quality of life is assessed Patients are followed every 3 months.

    PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study.

    53 locations

    United States (53)
    • University of Alabama Comprehensive Cancer Center
      Birmingham, Alabama, United States, 35294
    • Veterans Affairs Medical Center - Phoenix (Hayden)
      Phoenix, Arizona, United States, 85012
    • Comprehensive Blood and Cancer Center
      Bakersfield, California, United States, 93309
    • Pacific Coast Hematology/Oncology Medical Group
      Fountain Valley, California, United States, 92708
    • Scripps Clinic
      La Jolla, California, United States, 92037
    • Veterans Affairs Medical Center - West Los Angeles
      Los Angeles, California, United States, 90073
    • Southwest Cancer Care
      Poway, California, United States, 92064
    • University of California Davis Cancer Center
      Sacramento, California, United States, 95817
    • Kaiser Permanente-Southern California Permanente Medical Group
      San Diego, California, United States, 92120
    • Sidney Kimmel Cancer Center
      San Diego, California, United States, 92121
    • Oncology Clinic, P.C.
      Colorado Springs, Colorado, United States, 80909
    • Shands Cancer Center
      Gainesville, Florida, United States, 32610
    • Baptist Regional Cancer Institute - Jacksonville
      Jacksonville, Florida, United States, 32207
    • Oncology-Hematology Group of South Florida
      Miami, Florida, United States, 33176
    • Baptist Hospital- Pensacola
      Pensacola, Florida, United States, 32522
    • H. Lee Moffitt Cancer Center and Research Institute
      Tampa, Florida, United States, 33612
    • Medical College of Georgia Hospital and Clinics
      Augusta, Georgia, United States, 30912-3620
    • Evanston Northwestern Health Care
      Evanston, Illinois, United States, 60201
    • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
      Hines, Illinois, United States, 60141
    • Oncology and Hematology Associates, Inc.
      Indianapolis, Indiana, United States, 46219
    • Louisiana Oncology Associates
      Lafayette, Louisiana, United States, 70506
    • Alton Ochsner Medical Foundation Hospital
      New Orleans, Louisiana, United States, 70121
    • Henry Ford Hospital
      Detroit, Michigan, United States, 48202
    • St. Joseph Mercy Hospital
      Pontiac, Michigan, United States, 48341-2985
    • CCOP - Metro-Minnesota
      Saint Louis Park, Minnesota, United States, 55416
    • St. John's Mercy Medical Center
      Saint Louis, Missouri, United States, 63141
    • Cooper Cancer Institute
      Camden, New Jersey, United States, 08103
    • St. Barnabas Medical Center
      Livingston, New Jersey, United States, 07039
    • Cooper Hospital/University Medical Center
      Voorhees, New Jersey, United States, 08043
    • Santa Fe Hematology/Oncology
      Santa Fe, New Mexico, United States, 87505
    • Rochester General Hospital
      Rochester, New York, United States, 14621
    • State University of New York - Upstate Medical University
      Syracuse, New York, United States, 13210
    • Salem Research
      Winston-Salem, North Carolina, United States, 27103
    • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
      Winston-Salem, North Carolina, United States, 27157-1082
    • Ireland Cancer Center
      Cleveland, Ohio, United States, 44106-5065
    • Penn State Geisinger Cancer Center
      Hershey, Pennsylvania, United States, 17033
    • Central Pennsylvania Hematology & Medical Oncology Associates, PC
      Lemoyne, Pennsylvania, United States, 17043-1440
    • University of Pittsburgh Cancer Institute
      Pittsburgh, Pennsylvania, United States, 15213
    • Reading Hospital and Medical Center
      Reading, Pennsylvania, United States, 19612-6052
    • Brown University Oncology Group
      Providence, Rhode Island, United States, 02912
    • Cancer Centers of the Carolinas
      Greenville, South Carolina, United States, 29605
    • Spartanburg Regional Healthcare System
      Spartanburg, South Carolina, United States, 29303
    • Baptist Regional Cancer Center - Knoxville
      Knoxville, Tennessee, United States, 37901
    • Sarah Cannon-Minnie Pearl Cancer Center
      Nashville, Tennessee, United States, 37203
    • Texas Cancer Care
      Fort Worth, Texas, United States, 76104
    • University of Texas Medical Branch
      Galveston, Texas, United States, 77555-0209
    • University of Texas - MD Anderson Cancer Center
      Houston, Texas, United States, 77030-4009
    • Joe Arrington Cancer Center
      Lubbock, Texas, United States, 79410
    • Scott and White Memorial Hospital
      Temple, Texas, United States, 76508
    • Office of Michael E. Lee
      Norfolk, Virginia, United States, 23502
    • Hematology & Oncology Associates of Virginia
      Richmond, Virginia, United States, 23226
    • Oncology and Hematology Associates of Southwest Virginia, Inc.
      Roanoke, Virginia, United States, 24014
    • Waukesha Memorial Hospital
      Waukesha, Wisconsin, United States, 53188
    Status:
    completed
    Type:
    Interventional
    Phase:
    Start:
    28 February, 1999
    Updated:
    07 January, 2014
    Participants:
    4
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