Finding studies
Finding studies
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Lead
National Institutes of Health Clinical Center (CC)
OBJECTIVES: I. Determine the efficacy of thalidomide with docetaxel in terms of clinical response in patients with androgen-independent metastatic prostate cancer. II. Compare the pharmacokinetics of docetaxel with or without thalidomide in these patients III. Determine whether any pharmacodynamic relationships exist between plasma concentrations and clinical activity or toxicity of these regimens in this patient population. IV. Compare changes in molecular markers of angiogenesis and markers of apoptosis after treatment with these regimens in these patients. PROTOCOL OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. Arm I: Patients receive docetaxel IV over 30 minutes once weekly for 3 weeks. Arm II: Patients receive oral thalidomide daily beginning on day 2 and docetaxel IV over 30 minutes on days 2, 9, and 16. Treatment continues every 28 days in both arms in the absence of unacceptable toxicity or disease progression. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 75 patients (25 to arm I and 50 to arm II) will be accrued for this study within 18 months.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
