Expired Study
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Buffalo, New York 14263


Purpose:

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 recurrent prostate cancer.


Study summary:

OBJECTIVES: Primary - Determine whether fulvestrant can slow the rise of prostrate-specific antigen (PSA) level in patients with early recurrent adenocarcinoma of the prostate after radical prostatectomy or irradiation. Secondary - Determine the utility of monitoring serum PSA in patients treated with this drug. - Determine the safety of this drug in these patients. - Determine changes in bone mineral density and markers of bone resorption in patients with PSA-only failure treated with this drug. OUTLINE: This is a parallel group study. Patients are stratified according to prior primary therapy (prostatectomy with or without radiotherapy vs definitive radiotherapy alone). Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 56 patients (28 per stratum) will be accrued for this study within 3 years.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate - Early recurrent disease, defined by 1 of the following criteria: - Prostate-specific antigen (PSA) ≥ 2.0 ng/mL AND clearly rising within the past 3 months for patients who underwent prior prostatectomy with or without radiotherapy - PSA ≥ 4.0 ng/mL AND clearly rising from the lowest value obtained within the past 6 months for patients who underwent prior definitive radiotherapy only - No evidence of clinical recurrence,* as defined by the following criteria: - Digital rectal exam negative - No local recurrence by CT scan or MRI of the pelvis - No evidence of bone metastasis by bone scan NOTE: *Prostascint scan results are not considered evidence of recurrence - Underwent prior curative treatment comprising radical prostatectomy with or without adjuvant radiotherapy OR definitive radiotherapy alone - Testosterone (total or free) > than lower limit of normal PATIENT CHARACTERISTICS: Age - Any age Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - WBC > 3,500/mm^3 - Platelet count > 100,000/mm^3 - No history of bleeding diathesis Hepatic - INR < 1.6 - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - ALT or AST ≤ 2.5 times ULN - No severe hepatic impairment that would preclude study participation or compliance Renal - Creatinine ≤ 2.0 mg/dL - No severe renal impairment that would preclude study participation or compliance Cardiovascular - No unstable or uncompensated cardiac condition that would preclude study participation or compliance Pulmonary - No unstable or uncompensated respiratory condition that would preclude study participation or compliance Other - No history of hypersensitivity to active or inactive excipients of fulvestrant (e.g., castor oil) - No other severe condition that would preclude study compliance (e.g., abuse of alcohol or drugs or psychotic states) or participation PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - More than 6 months since prior neoadjuvant or adjuvant androgen deprivation therapy or luteinizing hormone-releasing hormone antagonist therapy - No other prior or concurrent hormonal therapy Radiotherapy - See Disease Characteristics - No concurrent radiotherapy Surgery - See Disease Characteristics Other - More than 4 weeks since prior experimental drug treatment - No concurrent anticoagulant therapy except antiplatelet therapy - No other concurrent therapy for prostate cancer - No other concurrent therapy known or suspected of altering androgen metabolism or androgen levels


NCT ID:

NCT00217464


Primary Contact:

Principal Investigator
Donald L. Trump, MD
Roswell Park Cancer Institute


Backup Contact:

N/A


Location Contact:

Buffalo, New York 14263
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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