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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00028769
First received: January 4, 2002
Last updated: June 12, 2013
Last verified: June 2013
  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
Drug: etoposide
Drug: flutamide
Drug: goserelin
Drug: leuprolide
Drug: nilutamide
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.

  • Overall Survival (OS) [ Time Frame: 0-5 years ] [ Designated as safety issue: No ]
    Overall survival is defined from the date of registration to date of death from any cause


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 41
Study Start Date: December 2001
Study Completion Date: July 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00028769     History of Changes
Other Study ID Numbers: CDR0000069132, S0032, U10CA032102
Study First Received: January 4, 2002
Results First Received: November 15, 2012
Last Updated: June 12, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Bicalutamide
Estramustine
Etoposide
Etoposide phosphate
Flutamide
Goserelin
Hormones
Leuprolide
Nilutamide
Paclitaxel
Alkylating Agents
Androgen Antagonists
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Fertility Agents
Fertility Agents, Female
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Mitosis Modulators

ClinicalTrials.gov processed this record on October 22, 2014