Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed Over 18 NCI SWOG-S0032 S0032, NCT00028769

Objectives

1. 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.
2. Determine the type, frequency, and severity of toxicity of this regimen in this patient population.

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

Biologic therapy:

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

Chemotherapy:

• 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

Radiotherapy:

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

Surgery:

• At least 4 weeks since prior surgery and recovered

Other:

• No concurrent bisphosphonates

Patient Characteristics:

Age:

• Over 18

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
• No active hypercoagulability

Hepatic:

• Not specified

Renal:

• Not specified

Cardiovascular:

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

Pulmonary:

• No history of pulmonary embolus

Other:

• 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

David Smith, MD, Protocol chair		Ph: 734-764-2248; 800-865-1125 Email: dcsmith@umich.edu

Registry Information
Official Title		Phase II Evaluation of Early Oral Estramustine, Oral Etoposide and Intravenous Paclitaxel in Combination with Hormone Therapy in Patients with High-Risk Metastic Adenocarinoma of the Prostate
Trial Start Date		2001-12-01
Registered in ClinicalTrials.gov		NCT00028769
Date Submitted to PDQ		2001-11-08
Information Last Verified		2005-03-07
NCI Grant/Contract Number		U10-CA32102

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