Fulvestrant in Treating Patients With Advanced Prostate Cancer

You may be eligible if

• 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