Official Title: “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.

Study Type: Interventional

Study Design: 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.

PROJECTED ACCRUAL: Approximately 55 patients will be accrued for this study.

Intervention(s) in this Clinical Trial

• Drug: bicalutamide
• Drug: docetaxel
• Drug: estramustine phosphate sodium
• Drug: leuprolide acetate

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: UMASS Memorial Cancer Center - University Campus

Overall Clinical Trial Officials and Contacts

Mary-Ellen Taplin, MD Study Chair UMASS Memorial Cancer Center - University Campus  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00003915

Study ID Number: CDR0000067095

ClinicalTrials.gov Identifier: NCT00003915

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database