Status:
COMPLETED
Fulvestrant in Treating Patients With Advanced Prostate Cancer
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
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 trea...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00244998
Start Date
September 1 2005
End Date
June 1 2012
Last Update
March 8 2013
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001