S0032, Combination Chemotherapy Plus Hormone Therapy in Treating Patients With Metastatic Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00028769
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : July 16, 2013
Last Update Posted : July 16, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Brief Summary:

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. Drugs such as goserelin, leuprolide, flutamide, or bicalutamide may stop the adrenal glands from producing androgens. Combining chemotherapy with hormone therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus hormone therapy in treating patients who have metastatic prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: bicalutamide Drug: estramustine Drug: etoposide Drug: flutamide Drug: goserelin Drug: leuprolide Drug: nilutamide Drug: paclitaxel Phase 2

Detailed Description:


  • Determine the progression-free and overall survival in patients with high-risk metastatic adenocarcinoma of the prostate treated with early estramustine, etoposide, and paclitaxel with combined androgen-blockade therapy.
  • Determine the type, frequency, and severity of toxicity of this regimen in this patient population.

OUTLINE: This is a multicenter study.

  • Androgen-blockade therapy: Patients receive a standard regimen of luteinizing hormone-releasing hormone agonist therapy comprising either goserelin subcutaneously once monthly or once every 3 months or leuprolide intramuscularly once monthly, once every 3 months, or once every 4 months. Patients also receive a standard regimen of antiandrogen therapy comprising oral bicalutamide, oral flutamide, or oral nilutamide once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
  • Chemotherapy: Beginning 14-30 days after initiation of androgen-blockade therapy, patients receive oral estramustine three times daily and oral etoposide once daily on days 1-14 and paclitaxel IV over 1 hour on day 2. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months until disease progression, every 6 months for 2 years, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 2 years.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Evaluation of Early Oral Estramustine, Oral Etoposide and Intravenous Paclitaxel in Combination With Hormone Therapy in Patients With High-Risk Metastatic Adenocarinoma of the Prostate
Study Start Date : December 2001
Actual Primary Completion Date : June 2010
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Hormone therapy, estramustine, etoposide and paclitaxel
Hormone therapy (leuprolide, bicalutamide, nilutamide, goserelin, flutamide), estramustine, etoposide and paclitaxel
Drug: bicalutamide Drug: estramustine
Other Name: estramustine phosphate sodium
Drug: etoposide Drug: flutamide Drug: goserelin Drug: leuprolide
Other Name: leuprolide acetate
Drug: nilutamide Drug: paclitaxel

Primary Outcome Measures :
  1. Progression-free Survival [ Time Frame: 0-5 years (assessed every 3 months if no progression when the chemotherapy had been finished. Once off chemotherapy, assessed every 3 months until progression) ]
    Measured from time of registration to time of first documentation of progression determined from the prostate-specific antigen (PSA) level, clinical criteria, or symptomatic deterioration. PSA progression is defined as a 25% increase greater than baseline. If the patient's PSA level had decrease during the study, a 25% increase from the nadir PSA level, with absolute value of >=5 ng/mL is considered progression. CLinical progress is defined as the appearance of any new lesion at any site or death without documented progression. Symptomatic deterioration is defined as a global deterioration of the health status requiring discontinuation of treatment without objective evidence of progression.

  2. Overall Survival (OS) [ Time Frame: 0-5 years ]
    Overall survival is defined from the date of registration to date of death from any cause

Secondary Outcome Measures :
  1. Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug [ Time Frame: up to 5 years after registration ]
    Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed high-risk adenocarcinoma of the prostate

    • Clinical stage D2 disease as evidenced by one of the following:

      • Visceral disease (liver, lung, or other viscera)
      • Bone metastases to sites in both the axial (spine, pelvis, ribs, or skull) and appendicular (claviculae, humeri, or femora) skeleton
  • No prior or concurrent (treated or untreated) brain metastases

    • Patients with clinical evidence of brain metastasis must have a negative brain CT or MRI
  • No evidence of untreated spinal cord compression



  • Over 18

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified


  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • No active hypercoagulability


  • Not specified


  • Not specified


  • No transient ischemic attacks, stroke, or myocardial infarction within the past 6 months
  • No active coronary artery disease requiring antianginal therapy
  • No active thrombophlebitis


  • No history of pulmonary embolus


  • No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated stage I or II cancer currently in complete remission


Biologic therapy:

  • At least 4 weeks since prior biologic therapy and recovered
  • No concurrent biologic therapy


  • No prior cytotoxic chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy:

  • Prior androgen-blockade therapy (e.g., luteinizing hormone-releasing hormone agonist and antiandrogen therapy) allowed if administered for a duration of less than 30 days
  • Prior neoadjuvant hormonal therapy allowed


  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy


  • At least 4 weeks since prior surgery and recovered


  • No concurrent bisphosphonates

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00028769

  Show 91 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: David C. Smith, MD University of Michigan Cancer Center

Responsible Party: Southwest Oncology Group Identifier: NCT00028769     History of Changes
Other Study ID Numbers: CDR0000069132
S0032 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Results First Posted: July 16, 2013
Last Update Posted: July 16, 2013
Last Verified: June 2013

Keywords provided by Southwest Oncology Group:
adenocarcinoma of the prostate
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Etoposide phosphate
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Fertility Agents, Female