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, Estramustine, and Thalidomide in Treating Patients With Prostate Cancer Previously Treated With Hormone Therapy

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: NCT00046826
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 4, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Thalidomide may stop the growth of prostate cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with thalidomide may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and estramustine with thalidomide in treating patients who have prostate cancer previously treated with hormone therapy.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: docetaxel Drug: estramustine phosphate sodium Drug: thalidomide Phase 2

Detailed Description:


  • Determine the objective response rate in patients with hormone-refractory prostate cancer treated with docetaxel, estramustine, and thalidomide.
  • Determine the safety and toxicity of this regimen in these patients.
  • Determine the efficacy of this regimen for pain control in these patients.

OUTLINE: Patients receive oral estramustine on days 1-3 and docetaxel IV over 1 hour on day 2 for 3 weeks. Treatment repeats every 4 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity.

Patients also receive oral thalidomide once daily beginning on day 1 and continuing for 1 year in the absence of disease progression or unacceptable toxicity.

Patients are followed monthly until disease progression.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 1 year.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Clinical Trial of Taxotere, Emcyt and Thalidomide (TET) for the Treatment of Hormone-Refractory Prostate Cancer
Study Start Date : September 2001
Actual Primary Completion Date : June 2007
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Objective response rate as measured by RECIST criteria and prostate-specific antigen (PSA) response 3 months, 6 months, and 1 year after treatment

Secondary Outcome Measures :
  1. Safety and toxicity as measured by CTC toxicity grading at baseline and during every visit
  2. Effectiveness of taxotere, emcyt, and thalidomide in pain control as measured by the pain scale at baseline and during every visit

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)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the prostate
  • Prior treatment with androgen ablation including:

    • Orchiectomy OR
    • Luteinizing hormone-releasing hormone (LHRH) therapy (e.g., leuprolide)

      • Patients on leuprolide must continue to receive the drug
  • Prior nonsteroidal antiandrogens (e.g., flutamide, bicalutamide, or nilutamide) required
  • Metastatic disease with disease progression during androgen ablation, defined by at least 1 of the following:

    • 2 consecutive increased prostate-specific antigen (PSA) levels measured at least 1 week apart
    • More than 25% increase in bidimensionally measurable soft tissue metastases
    • 20% increase in the sum of the baseline sum of longest diameter of measurable lesions
    • Appearance of new lesions
    • Appearance of new foci on a radionuclide bone scan
  • PSA greater than 10 ng/dL
  • Testosterone no greater than 50 ng/mL (castrate level)
  • No CNS metastases



  • Over 18

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • More than 16 weeks


  • WBC greater than 3,500/mm3
  • Absolute neutrophil count greater than 1,500/mm3
  • Platelet count greater than 100,000/mm3
  • Hemoglobin at least 8 g/dL


  • AST and/or ALT no greater than 2.5 times upper limit of normal (ULN) if alkaline phosphatase no greater than ULN OR
  • Alkaline phosphatase no greater than 4 times ULN if AST/ALT no greater than ULN
  • Bilirubin no greater than ULN


  • Creatinine less than 2.2 mg/dL


  • No myocardial infarction within the past 6 months
  • No New York Heart Association class III or IV heart disease
  • No history of arterial or venous thrombosis
  • No cerebrovascular accident within the past year


  • No history of pulmonary embolism


  • Fertile patients must use effective contraception during and for 4 weeks after study
  • No peripheral neuropathy grade 2 or greater
  • No active infection
  • No serious concurrent medical illness that would preclude study
  • No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
  • No other prior or concurrent active malignancy within the past 2 years except non-melanoma skin cancers
  • No other medical condition or reason that would preclude study


Biologic therapy:

  • Not specified


  • No prior chemotherapy for prostate cancer

Endocrine therapy:

  • See Disease Characteristics
  • At least 4 weeks since prior flutamide (6 weeks for bicalutamide or nilutamide) and continued evidence of disease progression (rising PSA)
  • Prior steroids for prostate cancer allowed
  • No concurrent steroids except for pre-medication for docetaxel


  • At least 4 weeks since prior radiotherapy


  • See Disease Characteristics


  • No concurrent herbal supplements to treat prostate cancer

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): NCT00046826

Layout table for location information
United States, Connecticut
Whittingham Cancer Center at Norwalk Hospital
Norwalk, Connecticut, United States, 06856
Carl and Dorothy Bennett Cancer Center at Stamford Hospital
Stamford, Connecticut, United States, 06904
Sponsors and Collaborators
Western Connecticut Health Network
Layout table for investigator information
Study Chair: Richard C. Frank, MD Western Connecticut Health Network
Publications of Results:
Frank RC, Coscia A, Versea L, et al.: Low dose docetaxel, estramustine and thalidomide followed by maintenance thalidomide for the treatment of hormone refractory prostate cancer (HRPC): a phase II community based trial. [Abstract] J Clin Oncol 22 (Suppl 14): A-4681, 426s, 2004.

Layout table for additonal information Identifier: NCT00046826    
Other Study ID Numbers: CDR0000069081
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: January 2006
Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage IV prostate cancer
recurrent prostate cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
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
Antineoplastic Agents, Alkylating
Alkylating Agents
Antineoplastic Agents, Hormonal