Phase II Trial of Transdermal Estradiol for Hormone Refractory Prostate Cancer

NCT ID: NCT00176644

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2008-12-31

Brief Summary

Multiple trials have shown the efficacy of estrogen therapy in metastatic prostate cancer, and most recently trials have supported the use of transdermal estrogens (patch) in the patient population with a decreased risk of cardiovascular disease as compared to the oral estrogens. We plan to study the use of transdermal estrogen at a dose of 0.4mg qd. We will evaluate the toxicities and measure quality of life. We will assess PSA response and measurable disease response. This will be a trial available to the Cancer Institute of New Jersey Oncology Group. We will enroll a total of 33 patients. We will plan to enroll 10 at CINJ.Patients will wear the patches (4) continuously. We will obtain blood work and clinic evaluations every three weeks. We will assess quality of life through a questionnaire given to patient every three weeks.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transdermal estradiol

Group Type: EXPERIMENTAL

Transdermal Estradiol

Intervention Type: DRUG

application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.

The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed.

Interventions

Transdermal Estradiol

application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.

The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with metastatic prostate adenocarcinoma, who have failed initial hormone therapy and who have had progression after at least one chemotherapy regimen that included docetaxel. Patients on antiandrogens must have progression after withdrawal of the antiandrogen for 4 weeks (flutamide) or 6 weeks (bicalutamide).
• PSA ≥ 10 ng/ml.
• Patients who have received LHRH agonist therapy for > 1 month must maintain agonist therapy while on-study. Patients who have not received agonist therapy or received < 1 month of therapy, may not begin or continue agonist therapy while on-study.
• Age >18 years and an estimated life expectancy of at least 4 months.
• ECOG performance status ≤ 2 (see Appendix B).
• Full recovery from the effects of any prior surgery or radiation therapy within 4 weeks of study entry.
• Serum creatinine ≤ 1.5 x ULN
• Total bilirubin < ULN
• Transaminases (SGOT and/or SGPT) ≤ 2 X institutional upper limit.
• Capacity to give informed, written consent.

Exclusion Criteria

• Any coexisting medical condition precluding full compliance with the study.
• Any history of deep venous thrombosis (DVT) or pulmonary embolus. Patients with a DVT on anticoagulants for ≥ 6 months will be eligible.
• Known CNS metastasis.
• The discontinuation of flutamide or bicalutamide < 4 or 6 weeks respectively.
• History of severe cardiovascular disease (AHA class III or IV; see Appendix C), uncontrolled CHF or life threatening cardiac dysrhythmia in the past 6 months.
• Herbal supplements may not be used while on-study and patients must have discontinued use for ≥ 1 week before entering on-study.
• Patients with a known hypersensitivity to estrogen.
• Triglyceride > 200 mg/dl.
• Prior estramustine.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Medicine and Dentistry of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Stein, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

CentraState Healthcare System

Freehold, New Jersey, United States

Robert Wood Johnson University Hospital/CINJ at Hamilton

Hamilton, New Jersey, United States

Morristown Memorial Hospital

Morristown, New Jersey, United States

Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Saint Peter's University Hospital

New Brunswick, New Jersey, United States

Overlook Hospital

Summit, New Jersey, United States

Countries

United States

Other Identifiers

CINJ 080419

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA072720

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000445280

Identifier Type: -

Identifier Source: org_study_id

NCT00255632

Identifier Type: -

Identifier Source: nct_alias