Fulvestrant in Treating Patients With Advanced Prostate Cancer

Roswell Park Comprehensive Cancer Center

Status and phase

Completed

Phase 2

Conditions

Prostate Cancer

Treatments

Drug: fulvestrant

Study type

Interventional

Funder types

Other

Identifiers

NCT00244998

I 53805

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

20 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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