Fulvestrant in Treating Patients With Advanced Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00244998
First received: October 25, 2005
Last updated: March 7, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Prostate Cancer
Drug: fulvestrant
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Fulvestrant (Faslodex®) in Androgen Independent Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Prostate-specific antigen (PSA) objective response rate (complete response [CR] or partial response [PR]) [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: Every Month ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: September 2005
Study Completion Date: June 2012
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: fulvestrant
    IM
Detailed Description:

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

  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 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

PATIENT CHARACTERISTICS:

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • 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)

Hepatic

  • 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

Renal

  • Creatinine < 2.5 mg/dL

Cardiovascular

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

    • Stable exertional angina allowed

Other

  • 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)

PRIOR CONCURRENT THERAPY:

Biologic therapy

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

Chemotherapy

  • 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

Radiotherapy

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

Surgery

  • See Disease Characteristics
  • See Endocrine therapy

Other

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00244998

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

Additional Information:
No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00244998     History of Changes
Other Study ID Numbers: I 53805
Study First Received: October 25, 2005
Last Updated: March 7, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Fulvestrant
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on April 15, 2014