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Treatment of Metastatic Prostate Cancer That is Hormone-Independent: Evaluation of the Role of Chemotherapy on the Quality of Life of Patients. Phase II Study (NCT00003682)

RATIONALE: Drugs used in chemotherapy use different ways to make cancer cells stop dividing so they stop growing or die. Combining chemotherapy with corticosteroids may be an effective treatment for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of methylprednisolone with or without doxorubicin in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
  • Drug: doxorubicin hydrochloride
    • Drug: methylprednisolone
      Ages eligible for Study
      18 Years to 120 Years
      Genders eligible for Study
      Accepts Healthy Volunteers
      OBJECTIVES: I. Determine the effect of weekly doxorubicin on the quality of life of patients with metastatic, hormone-refractory, symptomatic prostate cancer. II. Determine the contribution of this treatment on control of pain in these patients. III. Determine the toxicity of this regimen in these patients. IV. Determine the objective response and biological observations in these patients after this treatment. V. Determine the effect of this regimen on survival of these patients.

      OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive methylprednisolone IV weekly for 3 months. Arm II: Patients receive methylprednisolone IV and doxorubicin IV weekly for 3 months. Quality of life is assessed before treatment, every 4 weeks during treatment, and then every 3 months. Patients are followed every 3 months.

      PROJECTED ACCRUAL: A total of 160 patients will be accrued for this study within 3 years.

      15 locations

      France (15)
      • Institut Sainte Catherine
        Not specified
        Avignon, France, 84082
      • Centre de Lute Contre le Cancer,Georges-Francois Leclerc
        Not specified
        Dijon, France, 21079
      • Centre Leon Berard
        Not specified
        Lyon, France, 69373
      • Institut J. Paoli and I. Calmettes
        Not specified
        Marseille, France, 13273
      • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
        Not specified
        Montpellier, France, 34298
      • CRLCC Nantes - Atlantique
        Not specified
        Nantes-Saint Herblain, France, 44805
      • Centre Antoine Lacassagne
        Not specified
        Nice, France, 06189
      • C.H.U. - Hopital Gaston Doumergue
        Not specified
        Nimes, France, 30006
      • Institut Mutualiste Montsouris
        Not specified
        Paris, France, 75013
      • Hotel Dieu de Paris
        Not specified
        Paris, France, 75181
      • Institut Jean Godinot
        Not specified
        Reims, France, 51056
      • Centre Eugene Marquis
        Not specified
        Rennes, France, 35064
      • Centre Henri Becquerel
        Not specified
        Rouen, France, 76038
      • Centre Rene Huguenin
        Not specified
        Saint Cloud, France, 92211
      • Centre Hospitalier General de Saint Nazaire
        Not specified
        Saint Nazaire, France, 44600
      30 September, 1998
      21 June, 2016
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