Docetaxel, Estramustine, and Thalidomide in Treating Patients With Androgen-Independent Metastatic Adenocarcinoma of the Prostate

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00083005
First received: May 14, 2004
Last updated: March 14, 2012
Last verified: March 2012
  Purpose

RATIONALE: Drugs used in chemotherapy, such as docetaxel and estramustine, work in 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. Giving chemotherapy together with thalidomide may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel and estramustine together with thalidomide works in treating patients with androgen-independent metastatic adenocarcinoma (cancer) of the prostate.


Condition Intervention Phase
Prostate Cancer
Drug: docetaxel
Drug: estramustine phosphate sodium
Drug: thalidomide
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial Combining Estramustine, Docetaxel And 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):

Primary Outcome Measures:
  • PSA response [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Survival [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2004
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the prostate-specific antigen response in patients with androgen-independent metastatic adenocarcinoma of the prostate treated with docetaxel, estramustine, and thalidomide.

Secondary

  • Determine the survival duration in patients treated with this regimen.
  • Determine the pharmacokinetics of both docetaxel and thalidomide in patients treated with this regimen.
  • Determine whether any pharmacodynamic relationships exist between plasma concentrations of docetaxel and/or thalidomide and clinical activity or toxicity of this regimen in these patients.
  • Determine the existence of and quantification of circulating prostate cancer cells in patients before and after treatment with this regimen.
  • Determine genotype, with regard to cytochrome P450 2C19 polymorphism, in patients treated with this regimen.
  • Correlate genotype with pharmacokinetics and efficacy of this regimen in these patients.
  • Determine the changes in molecular markers of angiogenesis (including, but not limited to, serum and urine vascular endothelial growth factor) in patients before and after treatment with this regimen.
  • Determine the toxicity profile of this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive docetaxel IV over 30 minutes on days 2, 9, and 16, oral thalidomide once daily on days 1-28, and oral estramustine three times daily on days 1-3, 8-10, and 15-17. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 33-60 patients will be accrued for this study within 11-20 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate

    • Metastatic disease
    • Androgen-independent disease
  • Clinically progressive disease documented by at least 1 of the following parameters:

    • Two consecutively rising prostate-specific antigen (PSA) levels taken at least 1 week apart

      • PSA ≥ 5.0 ng/mL
      • Continued rise in PSA 4 weeks after discontinuation of prior flutamide OR 6 weeks after discontinuation of prior bicalutamide or nilutamide (for patients treated with anti-androgen agents)
    • At least 1 new lesion on bone scan
    • Progressive measurable disease
  • Must have undergone bilateral surgical castration OR continue on a gonadotropin-releasing hormone agonist
  • No brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3*
  • Hemoglobin ≥ 7.5 g/dL* NOTE: *No transfusions within the past 2 weeks

Hepatic

  • AST and ALT < 2.5 times upper limit of normal (ULN)
  • Bilirubin < ULN (≤ 3.0 times ULN for patients with Gilbert's syndrome)
  • Alkaline phosphatase ≤ 2.5 times ULN OR
  • Fractionated hepatic alkaline phosphatase ≤ 2.5 times ULN

Renal

  • Creatinine ≤ 1.5 mg/dL OR
  • Creatinine clearance ≥ 40 mL/min

Cardiovascular

  • No transient ischemic attacks or cerebrovascular accident within the past 2 years
  • No myocardial infarction within the past 6 months
  • No uncontrolled congestive heart failure
  • No uncontrolled angina pectoris
  • No thromboembolic disease

Other

  • No peripheral neuropathy ≥ grade 2
  • No cognitive impairment that would preclude study participation or giving informed consent
  • No other active malignancy within the past 2 years except non-melanoma skin cancer or superficial bladder carcinoma
  • Fertile patients must use effective contraception for at least 1 month before, during, and for at least 1 month after study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior thalidomide

Chemotherapy

  • No prior docetaxel
  • No prior estramustine
  • No prior chemotherapy for metastatic prostate cancer

Endocrine therapy

  • See Disease Characteristics

Radiotherapy

  • Recovered from prior radiotherapy

Surgery

  • See Disease Characteristics
  • Recovered from prior surgery

Other

  • No concurrent antiretroviral therapy for HIV-positive patients
  • No concurrent complementary or alternative therapy that would interact with study drugs
  • No concurrent herbal or nutritional products or dietary supplements that would interact with study drugs
  • No concurrent aprepitant as secondary prophylaxis or antiemetic treatment
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00083005

Locations
United States, Maryland
NCI - Center for Cancer Research
Bethesda, Maryland, United States, 20892
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
Investigators
Study Chair: Avi S. Retter, MD Eastchester Center for Cancer Care
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00083005     History of Changes
Obsolete Identifiers: NCT00078650
Other Study ID Numbers: 040132, 04-C-0132, CDR0000361758
Study First Received: May 14, 2004
Last Updated: March 14, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
adenocarcinoma of the prostate
recurrent prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Androgens
Estramustine
Docetaxel
Thalidomide
Sodium phosphate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 22, 2014