Paclitaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer

June 13, 2023 updated by: Eastern Cooperative Oncology Group

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

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel plus estramustine in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
      • Pretoria, South Africa, 0001
        • Pretoria Academic Hospital
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
      • Chicago, Illinois, United States, 60611
        • Veterans Affairs Medical Center - Chicago (Lakeside)
      • Decatur, Illinois, United States, 62526
        • CCOP - Central Illinois
      • Peoria, Illinois, United States, 61602
        • CCOP - Illinois Oncology Research Association
      • Urbana, Illinois, United States, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Veterans Affairs Medical Center - Indianapolis (Roudebush)
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Hospitals
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403-1206
        • CCOP - Cedar Rapids Oncology Project
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • CCOP - Ochsner
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02111
        • New England Medical Center Hospital
    • Michigan
      • Kalamazoo, Michigan, United States, 49007-3731
        • CCOP - Kalamazoo
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55416
        • CCOP - Metro-Minnesota
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • CCOP - Missouri Valley Cancer Consortium
    • New Jersey
      • East Orange, New Jersey, United States, 07018-1095
        • Veterans Affairs Medical Center - East Orange
      • Hackensack, New Jersey, United States, 07601
        • CCOP - Northern New Jersey
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Cancer Center
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • CCOP - Merit Care Hospital
    • Ohio
      • Cleveland, Ohio, United States, 44106-5065
        • Ireland Cancer Center
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822-2001
        • CCOP - Geisinger Clinical and Medical Center
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Cancer Center
      • Wynnewood, Pennsylvania, United States, 19096
        • CCOP - MainLine Health
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Veterans Affairs Medical Center - Madison
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Comprehensive Cancer Center
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin
      • Milwaukee, Wisconsin, United States, 53295
        • Veterans Affairs Medical Center - Milwaukee (Zablocki)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Cooperative Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Gary R. Hudes, MD, Fox Chase Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Hudes GR, Manola J, Conroy J, et al.: Phase II study of weekly paclitaxel (P) by 1-hour infusion plus reduced-dose oral estramustine (EMP) in metastatic hormone-refractory prostate carcinoma (HRPC): a trial of the Eastern Cooperative Oncology Group. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-697, 2001.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 1999

Primary Completion (Actual)

April 1, 2005

Study Registration Dates

First Submitted

November 6, 2000

First Submitted That Met QC Criteria

May 21, 2004

First Posted (Estimated)

May 24, 2004

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000066691
  • E-1898

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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