Fulvestrant in Treating Patients With Advanced 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: NCT00244998
Recruitment Status : Completed
First Posted : October 27, 2005
Last Update Posted : March 8, 2013
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Brief Summary:

RATIONALE: Estrogen may cause the growth of prostate cancer cells. Hormone therapy using fulvestrant may fight prostate cancer by blocking the use of estrogen by the tumor cells.

PURPOSE: This phase II trial is studying how well fulvestrant works in treating patients with advanced prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: fulvestrant Phase 2

Detailed Description:



  • Determine if the prostate-specific antigen objective response (complete and partial response) rate is > 0.2 in patients with androgen-independent advanced prostate cancer treated with fulvestrant.


  • Determine the toxicity of this drug in these patients.

OUTLINE: This is an open-label study.

Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Courses repeat once a month in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for survival.

PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Fulvestrant (Faslodex®) in Androgen Independent Prostate Cancer
Study Start Date : September 2005
Actual Primary Completion Date : October 2006
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Fulvestrant

Intervention Details:
  • Drug: fulvestrant

Primary Outcome Measures :
  1. Prostate-specific antigen (PSA) objective response rate (complete response [CR] or partial response [PR]) [ Time Frame: Monthly ]

Secondary Outcome Measures :
  1. Toxicity [ Time Frame: Every Month ]

Information from the National Library of Medicine

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


  • Histologically or cytologically confirmed adenocarcinoma of the prostate

    • Advanced disease
  • Must have androgen-independent prostate cancer meeting the following criteria:

    • Evidence of rising prostate-specific antigen (PSA) level and absolute value ≥ 5 ng/mL based on 2 measurements taken ≥ 2 weeks apart (measurements must be done after androgen deprivation [orchiectomy or luteinizing hormone-release hormone (LHRH) analogue] and antiandrogen withdrawal)
  • Rising PSA required for ≥ 28 days after antiandrogen or progestational therapy for prostate cancer (≥ 42 days after bicalutamide or nilutamide)
  • Testosterone < 50 ng/mL (unless surgically castrated)
  • Measurable or evaluable disease

    • PSA elevation constitutes evaluable disease


Performance status

  • ECOG 0-2

Life expectancy

  • Not specified


  • WBC > 3,000/mm^3
  • Neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8 g/dL (transfusion or epoetin alfa allowed)
  • No bleeding diathesis (e.g., disseminated intravascular coagulation or clotting factor deficiency)


  • Bilirubin normal

    • Gilbert's disease with bilirubin ≤ 3 times upper limit of normal (ULN) allowed in the absence of other etiology (e.g., hemolysis-reticulocyte count < 5%) and liver function tests normal
  • SGOT and/or SGPT ≤ 2 times ULN
  • INR < 1.6


  • Creatinine < 2.5 mg/dL


  • No unstable cardiac disease requiring medication
  • No new onset crescendo or rest angina

    • Stable exertional angina allowed


  • Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment
  • No other active malignancy within the past 2 years except nonmelanoma skin cancer or superficial bladder cancer
  • No history of significant neurologic or psychiatric disorders, including psychotic disorders, dementia, or seizures
  • No other serious illness or medical condition
  • No active infection
  • No known hypersensitivity to active or inactive excipients of fulvestrant (e.g., castor oil or mannitol)


Biologic therapy

  • Prior retinoids, vaccines, and cytokines are not considered cytotoxic and are allowed


  • No more than 1 prior cytotoxic chemotherapy regimen
  • More than 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas)
  • No concurrent chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • Prior glucocorticoids, antiandrogens, progestational agents, estrogens, and LHRH analogues are not considered cytotoxic and are allowed
  • At least 4 weeks since prior flutamide (6 weeks for bicalutamide or nilutamide)
  • Concurrent megestrol acetate allowed at a stable dose of ≤ 40 mg/day
  • Concurrent androgen deprivation using LHRH analogues allowed but must continue during study treatment or orchiectomy is required to maintain castrate levels of testosterone


  • More than 3 weeks since prior radiotherapy
  • No concurrent radiotherapy


  • See Disease Characteristics
  • See Endocrine therapy


  • Recovered from all prior therapy
  • Prior cholecalciferol analogues, ketoconazole, aminoglutethimide, peroxisome-proliferation-activated receptor-gamma agonists or antagonists, or PC-SPES are not considered cytotoxic and are allowed
  • No prior long-term anticoagulation therapy (antiplatelet therapy allowed)
  • More than 4 weeks since prior investigational drugs
  • No other concurrent anticancer therapy (e.g., PC-SPES)
  • No concurrent bisphosphonates unless receiving a stable dose at study entry
  • No concurrent therapy that may alter androgen metabolism or androgen levels
  • No concurrent full anticoagulation

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): NCT00244998

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Principal Investigator: Donald L. Trump, MD Roswell Park Cancer Institute

Responsible Party: Roswell Park Cancer Institute Identifier: NCT00244998     History of Changes
Other Study ID Numbers: I 53805
First Posted: October 27, 2005    Key Record Dates
Last Update Posted: March 8, 2013
Last Verified: March 2013

Keywords provided by Roswell Park Cancer Institute:
adenocarcinoma of the prostate
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs