Chemotherapy and Hormone Therapy in Treating Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00003915
• Other study ID #: CDR0000067095
• Secondary ID: UMASS-H-3745NCI-
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: March 1, 2017
• Start date: May 1999
• Est. completion date: February 2018

Study information

• Verified date: March 2017
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 63
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• bicalutamide

• docetaxel

• estramustine phosphate sodium

• leuprolide acetate

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Lahey Clinic - Burlington	Burlington	Massachusetts
United States	Norris Cotton Cancer Center	Lebanon	New Hampshire
United States	University of Massachusetts Memorial Medical Center - University Campus	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSA Progression Free Survival		years
Secondary	overall survival		years