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