Fulvestrant in Treating Patients With Recurrent Prostate Cancer

NCT00217464 | Terminated Phase 2 Results DMC

• 3 other identifiers: CDR0000441210RPCI-I-17203ZENECA-IRUSFULV0026
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; recurrent prostate cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of Participants With Progressive Disease at Day +90

  90, 60, and 30 days pre-treatment, the day of start therapy (day 0) and 30, 60 and 90 days post-treatment

Study Arms (1)

Fulvestrant

EXPERIMENTAL

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

Interventions

fulvestrant DRUG

intramuscularly

Fulvestrant

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Fulvestrant

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

716-845-2300

Study Officials

• Donald L. Trump, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: June 1, 2004
• Primary Completion: February 1, 2010
• Study Completion: March 1, 2010
• Last Updated: April 16, 2015
• Results First Posted: April 16, 2015

Record last verified: 2015-03

Locations

US (1)