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A Phase II Trial of Weekly Paclitaxel Plus Oral Estramustine in Patients With Hormone Refractory Prostate Cancer

Phase 2
Open (Enrolling)
Prostate Cancer

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Trial Information

A Phase II Trial of Weekly Paclitaxel Plus Oral Estramustine in Patients With Hormone Refractory Prostate Cancer

OBJECTIVES: I. Determine the response rate (PSA and/or objective response) and duration of
response to weekly paclitaxel plus estramustine in patients with metastatic hormone
refractory prostate cancer. II. Determine the effect on quality of life of this regimen in
these patients.

OUTLINE: Patients receive paclitaxel IV over 1 hour weekly for 4 weeks. Patients receive
oral estramustine the day before, the day of, and the day after paclitaxel administration
each week. Courses repeat every 4 weeks in the absence of unacceptable toxicity and disease
progression. A quality of life questionnaire is completed before treatment and 2 months
after treatment initiation.

PROJECTED ACCRUAL: A total of 17 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven metastatic (D1 or D2) hormone refractory
adenocarcinoma of the prostate with one of the following: -Bidimensionally measurable
disease -Bone only metastases with rising PSA levels -PSA only disease defined as rising
PSA levels with prior confirmation of D1 or D2 disease PSA must be greater than 8 if bone
only or PSA only disease Hormone failure defined as progression after treatment with
orchiectomy, LHRH agonist, DES alone, or any hormonal treatment in combination with
antiandrogen therapy

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Zubrod 0-2 Life
expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3
Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper
limit of normal (ULN) SGOT no greater than 2 times ULN Renal: Creatinine no greater than
2.0 mg/dL Other: No other active malignancies within the past 5 years except
nonmelanomatous skin cancer or other in situ cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks
since prior chemotherapy No prior estramustine alone or in combination with other
chemotherapy No prior taxanes No more than 1 prior chemotherapy regimen Endocrine therapy:
Concurrent primary hormonal therapy allowed (LHRH agonist or orchiectomy) At least 4 weeks
since prior antiandrogen therapy with at least 2 rises in PSA levels Radiotherapy: At
least 4 weeks since prior radiotherapy At least 8 weeks since prior strontium-89 therapy
Surgery: See Disease Characteristics

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Stuart P. Leitner, MD

Investigator Role:

Study Chair

Investigator Affiliation:

St. Barnabas Medical Center


United States: Federal Government

Study ID:




Start Date:

October 1998

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms



St. Barnabas Medical Center Livingston, New Jersey  07039
Monmouth Medical Center Long Branch, New Jersey  07740-6395