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

April 2, 2013 updated by: Nuvance Health

A Phase II Clinical Trial of Taxotere, Emcyt and Thalidomide (TET) for the Treatment of Hormone-Refractory Prostate Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • 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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Norwalk, Connecticut, United States, 06856
        • Whittingham Cancer Center at Norwalk Hospital
      • Stamford, Connecticut, United States, 06904
        • Carl and Dorothy Bennett Cancer Center at Stamford Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • More than 16 weeks

Hematopoietic:

  • 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

Hepatic:

  • 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

Renal:

  • Creatinine less than 2.2 mg/dL

Cardiovascular:

  • 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

Pulmonary:

  • No history of pulmonary embolism

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • 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

Radiotherapy:

  • At least 4 weeks since prior radiotherapy

Surgery:

  • See Disease Characteristics

Other:

  • No concurrent herbal supplements to treat prostate cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Safety and toxicity as measured by CTC toxicity grading at baseline and during every visit
Effectiveness of taxotere, emcyt, and thalidomide in pain control as measured by the pain scale at baseline and during every visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nuvance Health

Investigators

  • Study Chair: Richard C. Frank, MD, Nuvance Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

October 3, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

April 4, 2013

Last Update Submitted That Met QC Criteria

April 2, 2013

Last Verified

January 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000069081
  • NH-0139
  • NCI-V01-1681

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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