fulvestrant in treating patients with advanced prostate cancer

Conditions: Prostate Cancer

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.

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.

Eligibility 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

Keywords: adenocarcinoma of the prostate stage iii prostate cancer stage iv prostate cancer