Clinical trial NCT00244998 (phase 2, status: completed)
Conditions: prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: fulvestrant
SMILES: [H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@]1([H])C3=CC=C(O)C=C3C[C@@H](CCCCCCCCCS(=O)CCCC(F)(F)C(F)(F)F)[C@@]21[H]
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