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Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Definitive Local Treatment


Phase 2
N/A
N/A
Open (Enrolling)
Male
Prostate Cancer

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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 CenterLebanon, New Hampshire  03756
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Lahey Clinic - BurlingtonBurlington, Massachusetts  01805
University of Massachusetts Memorial Medical Center - University CampusWorcester, Massachusetts  01655