Chemotherapy With or Without Biological Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      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. Biological
      therapies use different ways to stimulate the immune system and stop cancer cells from
      growing. It is not yet known which treatment regimen is more effective in treating metastatic
      prostate cancer.

      PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy
      with that of chemotherapy plus biological therapy in treating patients who have progressive
      or metastatic prostate cancer that has not responded to hormone therapy.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the effect of estramustine, mitoxantrone, and vinorelbine vs isotretinoin,
           interferon alfa, and paclitaxel on PSA response in patients with metastatic
           hormone-refractory prostate cancer.

        -  Determine the toxic effects of each regimen in this patient population.

        -  Determine the effect of each regimen on pain, fatigue, and quality of life in these
           patients.

        -  Determine the objective response rate among the subset of patients who have
           bidimensionally measurable disease to each regimen after treatment.

        -  Determine the effect of each regimen on peripheral blood mononuclear cell BCL-2 in these
           patients.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      disease (measurable vs nonmeasurable and elevated PSA). Patients are randomized to one of two
      treatment arms.

        -  Arm I: Patients receive vinorelbine IV over 10 minutes on days 2 and 9 followed by
           mitoxantrone IV over 10 minutes on day 2 only. Oral estramustine is administered every
           12 hours on days 1-5. Courses repeat every 3 weeks in the absence of unacceptable
           toxicity, disease progression, or administration of the maximum cumulative dose of
           mitoxantrone.

        -  Arm II: Patients receive oral isotretinoin and interferon alfa subcutaneously on days 1
           and 2 and paclitaxel IV over 1 hour on day 2 weekly for 6 weeks. Courses repeat every 8
           weeks in the absence of unacceptable toxicity or disease progression.

      Quality of life is assessed at baseline, on day 2 of courses 2, 4, and 6 (arm I), on day 22
      of course 1 and day 1 of courses 2 and 3 (arm II), and then at completion of treatment.

      Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
      annually thereafter.

      PROJECTED ACCRUAL: A total of 70-114 patients (35-57 per arm) will be accrued for this study
      within 14-23 months.
    

Intervention name(s): recombinant interferon alfa; estramustine phosphate sodium; isotretinoin; mitoxantrone hydrochloride; paclitaxel; vinorelbine ditartrate
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Interferons; Interferon-alpha; Paclitaxel; Vinorelbine; Mitoxantrone; Estramustine; Isotretinoin
Allocation: Randomized
Primary purpose: Treatment
Keywords: adenocarcinoma of the prostate; stage IV prostate cancer; recurrent prostate cancer