Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Definitive Local Treatment
N/A
N/A
Male
Prostate Cancer
Trial Information
Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Definitive Local Treatment
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
PSA Progression Free Survival
Outcome Time Frame:
years
Safety Issue:
No
Principal Investigator
William Walsh, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Massachusetts, Worcester
Authority:
United States: Federal Government
Study ID:
CDR0000067095
NCT ID:
NCT00003915
Start Date:
May 1999
Completion Date:
February 2014
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage I prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| Lahey Clinic - Burlington | Burlington, Massachusetts 01805 |
| University of Massachusetts Memorial Medical Center - University Campus | Worcester, Massachusetts 01655 |
