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Chemotherapy and Hormone Therapy in Treating Patients With Prostate Cancer

This study is ongoing, but not recruiting participants.

Sponsored by: UMASS Memorial Cancer Center - University Campus
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003915
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide and leuprolide may fight prostate cancer by reducing the production of androgens.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy consisting of docetaxel and estramustine plus hormone therapy in treating patients who have previously undergone radiation therapy or surgical removal of the prostate for stage I prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: bicalutamide
Drug: docetaxel
Drug: estramustine phosphate sodium
Drug: leuprolide acetate
Phase II

MedlinePlus related topics:   Cancer    Prostate Cancer   

Drug Information available for:   Docetaxel    Estramustine    Estramustine phosphate    Estramustine phosphate sodium    Leuprolide acetate    Leuprolide    Bicalutamide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Definitive Local Treatment

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   55
Study Start Date:   May 1999

Detailed Description:

OBJECTIVES:

  • Determine the feasibility of administering docetaxel plus estramustine in combination with androgen deprivation therapy in patients with PSA elevation following radiotherapy or radical prostatectomy for early prostate cancer.
  • Evaluate this regimen in terms of PSA response rate, response duration, and time to future therapeutic intervention in this patient population.
  • Evaluate testosterone, free testosterone, and sex hormone binding globulin in relation to this treatment regimen in these patients.

OUTLINE: Patients receive oral estramustine three times a day on days 1-5 and docetaxel IV over 1 hour on day 2. Treatment repeats every 3 weeks for 4 courses.

Patients receive oral bicalutamide daily beginning on week 12 and leuprolide intramuscularly every 3 months beginning on week 13. Treatment continues for 15 months.

Patients are followed every 3 months for 2 years, every 4 months for 1 year, and every 6 months thereafter until disease progression.

PROJECTED ACCRUAL: Approximately 55 patients will be accrued for this study.

  Eligibility
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate

    • No metastases
  • No measurable or evaluable disease
  • 2 consecutively rising PSA levels at least 2 weeks apart, despite prior radical prostatectomy or radiotherapy (external beam or implant)

    • PSA risen to twice nadir value post radiotherapy

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than upper limit of normal (ULN)
  • Must meet 1 of the following criteria:

    • SGOT and/or SGPT no greater than 2.5 times ULN AND alkaline phosphatase no greater than ULN
    • Alkaline phosphatase no greater than 4.0 times ULN AND SGOT and/or SGPT no greater than ULN
    • SGOT and SGPT no greater than 1.5 times ULN AND alkaline phosphatase no greater than 2.5 times ULN

Renal:

  • Not specified

Cardiovascular:

  • At least 6 months since prior myocardial infarction, angina, or New York Heart Association class III or IV heart disease
  • No active thrombophlebitis
  • At least 6 months since prior thromboembolic events including deep vein thrombosis and cerebrovascular accident

Other:

  • No other malignancies within the past 5 years except curatively treated basal cell skin cancer
  • No active infection
  • No significant neuropathy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior estramustine or suramin

Endocrine therapy:

  • At least 6 months since prior neoadjuvant or adjuvant hormonal therapy of no greater than 6 months duration
  • No concurrent corticosteroids

Radiotherapy:

  • Salvage radiotherapy post prostatectomy allowed

Surgery:

  • See Disease Characteristics
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003915

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center    
      Boston, Massachusetts, United States, 02215
Lahey Clinic - Burlington    
      Burlington, Massachusetts, United States, 01805
University of Massachusetts Memorial Medical Center - University Campus    
      Worcester, Massachusetts, United States, 01655
United States, New Hampshire
Norris Cotton Cancer Center    
      Lebanon, New Hampshire, United States, 03756-0002

Sponsors and Collaborators
UMASS Memorial Cancer Center - University Campus

Investigators
Study Chair:     Mary-Ellen Taplin, MD     UMASS Memorial Cancer Center - University Campus    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067095, UMASS-H-3745, NCI-V99-1546
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003915
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate  
stage I prostate cancer  

Study placed in the following topic categories:
Docetaxel
Prostatic Diseases
Genital Neoplasms, Male
Leuprolide
Estramustine
Bicalutamide
Urogenital Neoplasms
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms

Additional relevant MeSH terms:
Antineoplastic Agents, Hormonal
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Pharmacologic Actions
Androgen Antagonists
Neoplasms
Neoplasms by Site
Therapeutic Uses
Fertility Agents, Female
Fertility Agents
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on November 30, 2008




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