Status:
TERMINATED
Fulvestrant in Treating Patients With Recurrent Prostate Cancer
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Prostate Cancer
Eligibility:
MALE
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 whether fulvestrant can slow the rise of prostrate-specific antigen (PSA) level in patients with early recurrent adenocarcinoma of the prostate after radical prostate...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00217464
Start Date
June 1 2004
End Date
March 1 2010
Last Update
April 16 2015
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001