Chemotherapy and Hormone Therapy in Treating Patients With Prostate Cancer - Full Text View

Sponsor:	UMASS Memorial Cancer Center - University Campus
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003915

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	Intervention	Phase
Prostate Cancer	Drug: bicalutamide Drug: docetaxel Drug: estramustine phosphate sodium Drug: leuprolide acetate	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Definitive Local Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Estramustine phosphate sodium Leuprolide Leuprolide acetate Bicalutamide Docetaxel Estramustine Estramustine phosphate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	55
Study Start Date:	May 1999

Detailed 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.

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

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003915

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Lahey Clinic - Burlington
Burlington, Massachusetts, United States, 01805
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, United States, 01655
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002

Sponsors and Collaborators

UMASS Memorial Cancer Center - University Campus

Investigators

Study Chair:

Mary-Ellen Taplin, MD

UMASS Memorial Cancer Center - University Campus

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000067095, UMASS-H-3745, NCI-V99-1546
Study First Received:	November 1, 1999
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00003915 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the prostate
stage I prostate cancer

Additional relevant MeSH terms:

Prostatic Diseases
Genital Neoplasms, Male
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hormone Antagonists
Estramustine
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Reproductive Control Agents
Docetaxel
Neoplasms by Site
Leuprolide

Therapeutic Uses
Alkylating Agents
Antineoplastic Agents, Hormonal
Genital Diseases, Male
Pharmacologic Actions
Neoplasms
Androgen Antagonists
Fertility Agents, Female
Fertility Agents
Bicalutamide
Antineoplastic Agents, Alkylating
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 22, 2009