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Fulvestrant in Treating Patients With Advanced Prostate Cancer

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00244998
Enrollment
20
Registered
2005-10-27
Start date
2005-09-30
Completion date
2012-06-30
Last updated
2013-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate, stage III prostate cancer, stage IV prostate cancer

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.

Interventions

DRUGfulvestrant

IM

Sponsors

Roswell Park Cancer Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

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

Secondary

MeasureTime frame
ToxicityEvery Month

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026