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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

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

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


- 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

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

- 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.

Inclusion Criteria


- 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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

David C. Smith, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Michigan Cancer Center


United States: Federal Government

Study ID:




Start Date:

December 2001

Completion Date:

Related Keywords:

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



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