Fulvestrant in Treating Patients With Advanced Prostate Cancer

March 7, 2013 updated by: Roswell Park Cancer Institute

Phase II Study of Fulvestrant (Faslodex®) in Androgen Independent Prostate Cancer

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.

Study Overview

Status

Completed

Conditions

Prostate Cancer

Intervention / Treatment

Drug: fulvestrant

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.

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- New York
  - Buffalo, New York, United States, 14263-0001
    - Roswell Park Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Toxicity Time Frame: Every Month	Every Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roswell Park Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

October 25, 2005

First Submitted That Met QC Criteria