Fulvestrant in Treating Patients With Recurrent Prostate Cancer

March 31, 2015 updated by: Roswell Park Cancer Institute

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: fulvestrant
intramuscularly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Patients Who Respond to Treatment.
Time Frame: 90, 60, and 30 days pre-treatment, the day of start therapy (day 0) and 30, 60 and 90 days post-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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Progressive Disease at Day +90
Time Frame: 90, 60, and 30 days pre-treatment, the day of start therapy (day 0) and 30, 60 and 90 days post-treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roswell Park Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

September 20, 2005

First Submitted That Met QC Criteria

September 20, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

April 16, 2015

Last Update Submitted That Met QC Criteria

March 31, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000441210
  • RPCI-I-17203
  • ZENECA-IRUSFULV0026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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