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Fulvestrant in Treating Patients With Advanced Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
fulvestrant
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage III prostate cancer, stage IV prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Roswell Park Cancer Institute

Outcomes

Primary Outcome Measures

Prostate-specific antigen (PSA) objective response rate (complete response [CR] or partial response [PR])

Secondary Outcome Measures

Toxicity

Full Information

First Posted
October 25, 2005
Last Updated
March 7, 2013
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00244998
Brief Title
Fulvestrant in Treating Patients With Advanced Prostate Cancer
Official Title
Phase II Study of Fulvestrant (Faslodex®) in Androgen Independent Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage III prostate cancer, stage IV prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
fulvestrant
Intervention Description
IM
Primary Outcome Measure Information:
Title
Prostate-specific antigen (PSA) objective response rate (complete response [CR] or partial response [PR])
Time Frame
Monthly
Secondary Outcome Measure Information:
Title
Toxicity
Time Frame
Every Month

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald L. Trump, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States

12. IPD Sharing Statement

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Fulvestrant in Treating Patients With Advanced Prostate Cancer

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