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Treatment of Sarcomatous Kidney Cancer That is Metastatic in Adults With Doxorubicin and Ifosfamide. Phase II Study (NCT00003683)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining doxorubicin and ifosfamide in treating patients who have metastatic kidney cancer.
  • Drug: doxorubicin hydrochloride
    • Drug: ifosfamide
      Ages eligible for Study
      18 Years and older
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      OBJECTIVES: I. Determine the efficacy in terms of objective response after treatment with ifosfamide and doxorubicin in patients with metastatic sarcomatoid renal cell cancer. II. Determine the toxicity of this regimen in these patients. III. Determine the effect of this regimen on the survival of these patients.

      OUTLINE: This is a multicenter study. Patients receive doxorubicin IV on day 1 and ifosfamide IV over 2 hours on days 1 and 2. Treatment is repeated every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.

      PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 3 years.

      14 locations

      France (14)
      • Institut Sainte Catherine
        Not specified
        Avignon, France, 84082
      • 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
      • Hotel Dieu de Paris
        Not specified
        Paris, France, 75181
      • Institut Curie - Section Medicale
        Not specified
        Paris, France, 75248
      • Institut Jean Godinot
        Not specified
        Reims, France, 51056
      • Centre Eugene Marquis
        Not specified
        Rennes, France, 35064
      • Centre Rene Huguenin
        Not specified
        Saint Cloud, France, 92211
      • Centre Hospitalier General de Saint Nazaire
        Not specified
        Saint Nazaire, France, 44600
      • Institut Gustave Roussy
        Not specified
        Villejuif, France, F-94805
      Status:
      unknown
      Type:
      Interventional
      Phase:
      Start:
      28 February, 1998
      Updated:
      22 July, 2008
      Participants:
      40
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