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Intensive Chemotherapy With Peripheral Blood Stem Cell Support for Small Cell Lung Cancer (NCT00003860)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have small cell lung cancer.
  • Biological: filgrastim
    • Drug: carboplatin
      • Drug: etoposide
        • Drug: ifosfamide
          • Procedure: in vitro-treated peripheral blood stem cell transplantation
            Ages eligible for Study
            18 Years to 60 Years
            Genders eligible for Study
            All
            Accepts Healthy Volunteers
            No
            OBJECTIVES: I. Determine the feasibility of the administration of intensive chemotherapy with ifosfamide, carboplatin, and etoposide followed by peripheral blood stem cell support in patients with small cell lung cancer. II. Determine the rate and duration of response in these patients after this treatment. III. Determine the progression free and overall survival of these patients.

            OUTLINE: This is an open label, multicenter study. Patients receive 4 courses of intensive chemotherapy consisting of ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1 and 2. Filgrastim (G-CSF) is administered subcutaneously beginning on day 2 and continuing until blood cell counts recover. Courses repeat every 14 days. Peripheral blood stem cells (PBSC) are collected after course 1. PBSC are reinfused on day 3 of courses 2 and 3. Patients who experience a complete response receive prophylactic cerebral irradiation on day 71. Patients are followed every 2 months for 5 years.

            PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 18 months.

            22 locations

            France (22)
            • CHR de Besancon - Hopital Saint-Jacques
              Besancon, France, 25030
            • Institut Bergonie
              Bordeaux, France, 33076
            • CMC Bligny
              Briis Sous Forges, France, 91640
            • Centre de Lute Contre le Cancer,Georges-Francois Leclerc
              Dijon, France, 21079
            • CHR de Grenoble - La Tronche
              Grenoble, France, 38043
            • Centre Leon Berard
              Lyon, France, 69373
            • Hopital Louis Pradel
              Lyon, France, 69394
            • Institut J. Paoli and I. Calmettes
              Marseille, France, 13273
            • Hopital Arnaud de Villeneuve
              Montpellier, France, 34295
            • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
              Montpellier, France, 34298
            • Centre Antoine Lacassagne
              Nice, France, 06189
            • Institut Curie - Section Medicale
              Paris, France, 75248
            • Hopital Saint Antoine
              Paris, France, 75571
            • Hopital Tenon
              Paris, France, 75970
            • Hopital Jules Courmont - Centre Hospitalier Lyon Sud
              Pierre Benite, France, 69495
            • Hopital Rene Dubos
              Pontoise, France, 95300
            • Institut Jean Godinot
              Reims, France, 51056
            • Centre Rene Huguenin
              Saint Cloud, France, 92210
            • Hopitaux Universitaire de Strasbourg
              Strasbourg, France, 67091
            • Institut Claudius Regaud
              Toulouse, France, 31052
            • CHRU de Nancy - Hopitaux de Brabois
              Vandoeuvre-Les-Nancy, France, 54511
            • Institut Gustave Roussy
              Villejuif, France, F-94805
            Status:
            unknown
            Type:
            Interventional
            Phase:
            Start:
            31 August, 1998
            Updated:
            05 February, 2009
            Participants:
            36
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