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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00020046
First Posted: March 5, 2007
Last Update Posted: March 15, 2012
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.
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose

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 Intervention Phase
Stage IV Prostate Cancer Adenocarcinoma of the Prostate Recurrent Prostate Cancer Drug: docetaxel Drug: thalidomide Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Study Start Date: December 1999
Study Completion Date: September 2003
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Criteria

PROTOCOL ENTRY CRITERIA:

--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

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00020046


Locations
United States, Maryland
Medicine Branch
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Investigators
Study Chair: William Dahut National Cancer Institute (NCI)
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00020046     History of Changes
Obsolete Identifiers: NCT00001942
Other Study ID Numbers: 000033
00-C-0033
CDR0000067602
First Submitted: March 2, 2007
First Posted: March 5, 2007
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
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:
Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Docetaxel
Thalidomide
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


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