Fulvestrant in Treating Patients With Recurrent Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Multicenter Study of Fulvestrant (Faslodex®) in Early, Recurrent Prostate Cancer Following Local Therapy: A Phase II Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00217464
• Other study ID #: CDR0000441210
• Secondary ID: RPCI-I-17203ZENE
• Status: Terminated
• Phase: Phase 2
• First received: September 20, 2005
• Last updated: March 31, 2015
• Start date: June 2004
• Est. completion date: March 2010

Study information

• Verified date: March 2015
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: March 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• fulvestrant
intramuscularly

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Patients Who Respond to Treatment.	Response is defined to be the clear slowing of the rate of increase of PSA levels with time	90, 60, and 30 days pre-treatment, the day of start therapy (day 0) and 30, 60 and 90 days post-treatment	No
Secondary	Number of Participants With Progressive Disease at Day +90	Progressive Disease is defined as failure to achieve a statistically significant decrease in PSA rise after the day +90 PSA value	90, 60, and 30 days pre-treatment, the day of start therapy (day 0) and 30, 60 and 90 days post-treatment	No