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Phase II Study of Weekly Paclitaxel by 1-HR Infusion Plus Estramustine in Metastatic Hormone-Refractory Prostate Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

Phase II Study of Weekly Paclitaxel by 1-HR Infusion Plus Estramustine in Metastatic Hormone-Refractory Prostate Carcinoma


OBJECTIVES: I. Determine the effect of weekly paclitaxel plus estramustine on PSA response
in patients with metastatic hormone-refractory prostate cancer. II. Describe the toxic
effects of this treatment in this patient population. III. Determine the effect of treatment
on pain, asthenia, and quality of life. IV. Determine the objective response rate after
treatment among the patients with bidimensionally measurable disease.

OUTLINE: Patients receive estramustine orally twice a day on days 1-3 of each week for 6
weeks. Patients also receive paclitaxel IV over 1 hour on day 2 of each week for 6 weeks.
Courses repeat every 8 weeks in the absence of unacceptable toxicity and disease
progression. Quality of life is assessed prior to treatment and at weeks 4, 8, 20, and 24.
Patients are followed every 3 months for 2 years, every 6 months for years 2-5, and then
annually thereafter.

PROJECTED ACCRUAL: There will be 17-52 patients accrued into this study over 14 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed metastatic hormone-refractory
adenocarcinoma of the prostate gland Elevated serum acid phosphatase or PSA levels must
not be only evidence of disease Must have evidence of progressive metastatic disease
(e.g., bone, pelvic mass, lymph node, liver, or lung metastases) Radiological evidence of
hydronephrosis alone does not constitute evidence of metastatic disease Patients with bone
metastases only (i.e., lacking measurable soft tissue disease) must have PSA level of at
least 20 ng/mL Patients with soft tissue metastases and/or visceral disease must have
either bidimensionally measurable disease or a PSA level of at least 20 ng/mL Must have
had prior treatment with bilateral orchiectomy or other primary hormonal therapy (e.g.,
estrogen therapy, LHRH-blocker plus flutamide, etc.) with evidence of treatment failure No
carcinomatous meningitis or brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: WBC at least 4,000/mm3 OR Granulocyte count at least
2,000/mm3 Platelet count greater than 100,000/mm3 No history of deep venous thrombosis
Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT and SGPT no greater than 2 times normal
Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 50 mL/min
Cardiovascular: No active angina pectoris No known New York Heart Association class II-IV
heart disease No history of myocardial infarction in the last 6 months Other: No history
of prior malignancy except if curatively treated and disease free for time period
considered appropriate for cure of specific cancer No other serious concurrent illness or
active infection Effective contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy (including neoadjuvant chemotherapy) Endocrine therapy: See Disease
Characteristics At least 6 weeks since prior bicalutamide At least 4 weeks since prior
flutamide or nilutamide Recovered from prior toxicities of endocrine therapy Radiotherapy:
No prior strontium 89, samarium 153, or other radioisotope therapies At least 4 weeks
since prior radiotherapy and recovered Surgery: See Disease Characteristics Recovered from
prior surgery

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Gary R. Hudes, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066691

NCT ID:

NCT00003614

Start Date:

December 1998

Completion Date:

Related Keywords:

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

Name

Location

University of Rochester Cancer CenterRochester, New York  14642
Ireland Cancer CenterCleveland, Ohio  44106-5065
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Veterans Affairs Medical Center - Indianapolis (Roudebush)Indianapolis, Indiana  46202
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
New England Medical Center HospitalBoston, Massachusetts  02111
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
CCOP - Northern New JerseyHackensack, New Jersey  07601
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
CCOP - OchsnerNew Orleans, Louisiana  70121
CCOP - Merit Care HospitalFargo, North Dakota  58122
CCOP - Geisinger Clinical and Medical CenterDanville, Pennsylvania  17822-2001
Medical College of WisconsinMilwaukee, Wisconsin  53226
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
Veterans Affairs Medical Center - MadisonMadison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Veterans Affairs Medical Center - Milwaukee (Zablocki)Milwaukee, Wisconsin  53295
Veterans Affairs Medical Center - Chicago (Lakeside)Chicago, Illinois  60611
Indiana University HospitalsIndianapolis, Indiana  46202