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Fulvestrant in Treating Patients With Recurrent Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
fulvestrant
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fulvestrant

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 20, 2005
Last Updated
March 31, 2015
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00217464
Brief Title
Fulvestrant in Treating Patients With Recurrent Prostate Cancer
Official Title
Multicenter Study of Fulvestrant (Faslodex®) in Early, Recurrent Prostate Cancer Following Local Therapy: A Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
Closed for futility
Study Start Date
June 2004 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fulvestrant
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
fulvestrant
Intervention Description
intramuscularly
Primary Outcome Measure Information:
Title
Proportion of Patients Who Respond to Treatment.
Description
Response is defined to be the clear slowing of the rate of increase of PSA levels with time
Time Frame
90, 60, and 30 days pre-treatment, the day of start therapy (day 0) and 30, 60 and 90 days post-treatment
Secondary Outcome Measure Information:
Title
Number of Participants With Progressive Disease at Day +90
Description
Progressive Disease is defined as failure to achieve a statistically significant decrease in PSA rise after the day +90 PSA value
Time Frame
90, 60, and 30 days pre-treatment, the day of start therapy (day 0) and 30, 60 and 90 days post-treatment

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald L. Trump, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States

12. IPD Sharing Statement

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Fulvestrant in Treating Patients With Recurrent Prostate Cancer

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