Phase II Randomized Study of Docetaxel With or Without Thalidomide in Patients With Androgen-Independent Metastatic Prostate Cancer
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
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
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
Patients are followed every 2 months.
A total of 75 patients (25 to arm I and 50 to arm II) will be accrued for this study within
Primary Purpose: Treatment
National Cancer Institute (NCI)
United States: Federal Government
|Medicine Branch||Bethesda, Maryland 20892|