Docetaxel With or Without Thalidomide in Treating Patients With Metastatic Prostate Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of prostate cancer by stopping blood flow to the tumor.
PURPOSE: Randomized phase II trial to compare the effectiveness of docetaxel with or without thalidomide in treating patients who have metastatic prostate cancer.
|Stage IV Prostate Cancer Adenocarcinoma of the Prostate Recurrent Prostate Cancer||Drug: docetaxel Drug: thalidomide||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Randomized Study of Docetaxel With or Without Thalidomide in Patients With Androgen-Independent Metastatic Prostate Cancer|
|Study Start Date:||December 1999|
|Study Completion Date:||September 2003|
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.
A total of 75 patients (25 to arm I and 50 to arm II) will be accrued for this study within 18 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00020046
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||William Dahut||National Cancer Institute (NCI)|