Clinical trial NCT00217464: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate
recurrent prostate cancer
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 17
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Proportion of Patients Who Respond to Treatment.
timeFrame: 90, 60, and 30 days pre-treatment, the day of start therapy (day 0) and 30, 60 and 90 days post-treatment
Secondary outcomes:
measure: Number of Participants With Progressive Disease at Day +90
timeFrame: 90, 60, and 30 days pre-treatment, the day of start therapy (day 0) and 30, 60 and 90 days post-treatment
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Donald L. Trump, MD
role: PRINCIPAL_INVESTIGATOR
References: