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Chemotherapy and Hormone Therapy in Treating Patients With Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
William Walsh, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT00003915
First received: November 1, 1999
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Definitive Local Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • PSA Progression Free Survival [ Time Frame: years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: years ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: May 1999
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment Drug: bicalutamide Drug: docetaxel Drug: estramustine phosphate sodium Drug: leuprolide acetate

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 and/or subsequently until death. Information will be collected on subsequent prostate cancer treatments, time to and nature of first evidence of metastatic prostate cancer, and the date and cause of death.

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
University of Massachusetts, Worcester
Investigators
Principal Investigator: William Walsh, MD University of Massachusetts, Worcester
  More Information

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

No publications provided

Responsible Party: William Walsh, Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00003915     History of Changes
Other Study ID Numbers: CDR0000067095, UMASS-H-3745, NCI-V99-1546
Study First Received: November 1, 1999
Last Updated: January 17, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Massachusetts, Worcester:
adenocarcinoma of the prostate
stage I prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Estramustine
Leuprolide
Docetaxel
Bicalutamide
Sodium phosphate
Antineoplastic Agents, Hormonal
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Cathartics
Gastrointestinal Agents
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on June 18, 2013