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: February 18, 2014
Last verified: February 2014

November 1, 1999
February 18, 2014
May 1999
February 2015   (final data collection date for primary outcome measure)
PSA Progression Free Survival [ Time Frame: years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00003915 on ClinicalTrials.gov Archive Site
overall survival [ Time Frame: years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Chemotherapy and Hormone Therapy in Treating Patients With Prostate Cancer
Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Definitive Local Treatment

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Drug: bicalutamide
  • Drug: docetaxel
  • Drug: estramustine phosphate sodium
  • Drug: leuprolide acetate
Experimental: treatment
Interventions:
  • Drug: bicalutamide
  • Drug: docetaxel
  • Drug: estramustine phosphate sodium
  • Drug: leuprolide acetate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
63
February 2015
February 2015   (final data collection date for primary outcome measure)

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
Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003915
CDR0000067095, UMASS-H-3745, NCI-V99-1546
Yes
William Walsh, University of Massachusetts, Worcester
University of Massachusetts, Worcester
Not Provided
Principal Investigator: William Walsh, MD University of Massachusetts, Worcester
University of Massachusetts, Worcester
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP