Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Chemotherapy and Hormone Therapy in Treating Patients With Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Not specified	Other	UMASS-H-3745 NCI-V99-1546, NCT00003915

Objectives

1. 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.
2. Evaluate this regimen in terms of PSA response rate, response duration, and time to future therapeutic intervention in this patient population.
3. Evaluate testosterone, free testosterone, and sex hormone binding globulin in relation to this treatment regimen in these patients.

Entry 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

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

Patient Characteristics:

Age:

• Not specified

Performance status:

• 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,000/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

Approximately 55 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

UMASS Memorial Cancer Center - University Campus

Mary-Ellen Taplin, MD, Protocol chair(Contact information may not be current)		Ph: 508-856-2114

Registry Information
Official Title		Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients with a Rising PSA After Definitive Local Treatment
Trial Start Date		1999-05-01
Registered in ClinicalTrials.gov		NCT00003915
Date Submitted to PDQ		1999-06-02
Information Last Verified		2003-10-10

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