Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	Over 18	Other	NH-0139 NCI-V01-1681, NCT00046826

Objectives

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

Entry Criteria

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

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

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

Expected Enrollment

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

Outcomes

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

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

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.

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.

Trial Contact Information

Trial Lead Organizations

Whittingham Cancer Center at Norwalk Hospital

Richard Frank, MD, Protocol chair		Ph: 203-845-2132

Registry Information
Official Title		A Phase II Clinical Trial of Taxotere, Emcyt and Thalidomide (TET) for the Treatment of Hormone-Refractory Prostate Cancer
Trial Start Date		2001-09-20
Trial Completion Date		2007-06-07
Registered in ClinicalTrials.gov		NCT00046826
Date Submitted to PDQ		2001-10-17
Information Last Verified		2006-01-13

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