Fulvestrant in Treating Patients With Advanced Prostate Cancer

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Treatments: Estradiol; Fulvestrant

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