Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Combination Chemotherapy Plus Hormone Therapy in Treating Patients With Metastatic Prostate Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00028769
  Purpose

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 Intervention Phase
Prostate Cancer
Drug: bicalutamide
Drug: estramustine phosphate sodium
Drug: etoposide
Drug: flutamide
Drug: goserelin
Drug: leuprolide acetate
Drug: nilutamide
Drug: paclitaxel
Phase II

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Etoposide Paclitaxel Etoposide phosphate Estramustine Estramustine phosphate Estramustine phosphate sodium Goserelin Leuprolide acetate Leuprolide Flutamide Bicalutamide Nilutamide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: December 2001
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • 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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00028769

  Show 91 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: David C. Smith, MD University of Michigan Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000069132, SWOG-S0032
Study First Received: January 4, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00028769  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage IV prostate cancer
recurrent prostate cancer

Study placed in the following topic categories:
Genital Neoplasms, Male
Prostatic Diseases
Nilutamide
Estramustine
Goserelin
Urogenital Neoplasms
Flutamide
Genital Diseases, Male
Etoposide phosphate
Recurrence
Paclitaxel
Leuprolide
Bicalutamide
Adenocarcinoma
Prostatic Neoplasms
Etoposide

Additional relevant MeSH terms:
Antineoplastic Agents, Hormonal
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hormone Antagonists
Mitosis Modulators
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antimitotic Agents
Reproductive Control Agents
Pharmacologic Actions
Neoplasms
Androgen Antagonists
Neoplasms by Site
Fertility Agents, Female
Therapeutic Uses
Tubulin Modulators
Fertility Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009