COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Docetaxel With or Without Thalidomide in Treating Patients With Metastatic Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00020046
Recruitment Status : Completed
First Posted : March 5, 2007
Last Update Posted : March 15, 2012
Information provided by:
National Institutes of Health Clinical Center (CC)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Stage IV Prostate Cancer Adenocarcinoma of the Prostate Recurrent Prostate Cancer Drug: docetaxel Drug: thalidomide Phase 2

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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
Actual Study Completion Date : September 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)


--Disease Characteristics-- Histologically confirmed androgen-independent metastatic adenocarcinoma of the prostate Clinically progressive disease documented by at least 1 of the following: Two consecutively rising PSA levels (PSA at least 5.0) At least 1 new lesion on bone scan Progressive measurable disease If no prior surgical castration, serum testosterone must be less than 50 ng/mL and continue on gonadotropin-releasing hormone If receiving an antiandrogen and PSA level rising, must demonstrate a continued rise in PSA 4 weeks after stopping flutamide and 6 weeks after stopping bicalutamide or nilutamide No brain metastases --Prior/Concurrent Therapy-- Biologic therapy: No prior thalidomide Chemotherapy: No prior chemotherapy for metastatic prostate cancer No prior docetaxel Endocrine therapy: See Disease Characteristics Radiotherapy: Recovered from prior radiotherapy Surgery: See Disease Characteristics Recovered from prior surgery --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.0 mg/dL AST/ALT less than 2.5 times upper limit of normal (ULN) Alkaline phosphatase less than 2.5 times ULN Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 40 mL/min Cardiovascular: No history of myocardial infarction within past 6 months No uncontrolled congestive heart failure or angina pectoris Other: No other prior active malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the bladder Fertile patients must use effective contraception at least 1 month prior to, during, and for 1 month after study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00020046

Layout table for location information
United States, Maryland
Medicine Branch
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Layout table for investigator information
Study Chair: William Dahut National Cancer Institute (NCI)

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00020046    
Obsolete Identifiers: NCT00001942
Other Study ID Numbers: 000033
First Posted: March 5, 2007    Key Record Dates
Last Update Posted: March 15, 2012
Last Verified: March 2012
Keywords provided by National Institutes of Health Clinical Center (CC):
adenocarcinoma of the prostate
adult solid tumor
body system/site cancer
cellular diagnosis, prostate cancer
genetic condition
male reproductive cancer
prostate cancer
recurrent prostate cancer
solid tumor
stage IV prostate cancer
stage, prostate cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors