Clinical Trial: Chemotherapy and Hormone Therapy in Treating Patients With Prostate Cancer

This study is no longer recruiting patients.

Sponsored by: University of Massachusetts Medical Center
Information provided by: National Cancer Institute (NCI)

Purpose

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.

Condition Treatment or Intervention Phase
adenocarcinoma of the prostate
stage I prostate cancer
 Drug: bicalutamide
 Drug: docetaxel
 Drug: estramustine
 Drug: leuprolide
 Procedure: antiandrogen therapy
 Procedure: chemotherapy
 Procedure: endocrine therapy
 Procedure: hormone therapy
Phase II

MedlinePlus related topics:  Prostate Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Docetaxel Plus Estramustine in Combination With Androgen Deprivation Therapy in Patients With PSA Elevation Following Radiotherapy or Radical Prostatectomy for Early Prostate Cancer

Further Study Details: 

OBJECTIVES:

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.

Eligibility

Genders Eligible for Study:  Both

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:

Endocrine therapy:

  • At least 6 months since prior neoadjuvant or adjuvant hormonal therapy of no greater than 6 months duration
  • No concurrent corticosteroids

Radiotherapy:

Surgery:

  • See Disease Characteristics

Location Information


Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States

      Lahey Clinic - Burlington, Burlington,  Massachusetts,  01805,  United States

      University of Massachusetts Memorial Medical Center - University Campus, Worcester,  Massachusetts,  01655,  United States

New Hampshire
      Norris Cotton Cancer Center, Lebanon,  New Hampshire,  03756-0002,  United States

Study chairs or principal investigators

Mary Ellen Taplin, MD,  Study Chair,  University of Massachusetts Medical Center   

More Information

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

Study ID Numbers:  CDR0000067095; UMASS-H-3745; NCI-V99-1546
Record last reviewed:  November 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003915
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005