Fulvestrant in Treating Patients With Advanced Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00244998
• Other study ID #: I 53805
• Status: Completed
• Phase: Phase 2
• First received: October 25, 2005
• Last updated: March 7, 2013
• Start date: September 2005
• Est. completion date: June 2012

Study information

• Verified date: March 2013
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2012
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• fulvestrant
IM

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prostate-specific antigen (PSA) objective response rate (complete response [CR] or partial response [PR])		Monthly	No
Secondary	Toxicity		Every Month	Yes