Fulvestrant in Treating Patients With Recurrent Prostate Cancer

NCT ID: NCT00217464

Last Updated: 2015-04-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2010-03-31

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 II trial is studying how well fulvestrant works in treating patients with recurrent prostate cancer.

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 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 an open-label, single group assignment study.

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 32 patients will be accrued for this study for 84 months.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fulvestrant

Fulvestrant will be provided as 250 mg in 5 mL as a pre-tilled syringe. Fulvestrant will be administered as 500 mg, that is, 2 injections of 5 mL, one into each buttock im on day 0. A single 250 mg in 5 mL injection will be administered on day 14 followed by a single 250 mg in 5 mL dose on day 28 and monthly thereafter.

Group Type: EXPERIMENTAL

fulvestrant

Intervention Type: DRUG

intramuscularly

Interventions

fulvestrant

intramuscularly

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Donald L. Trump, MD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

RPCI-I-17203

Identifier Type: -

Identifier Source: secondary_id

ZENECA-IRUSFULV0026

Identifier Type: -

Identifier Source: secondary_id

CDR0000441210

Identifier Type: -

Identifier Source: org_study_id