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Phase II Trial of Transdermal Estradiol in Patients With Hormone Refractory Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

Phase II Trial of Transdermal Estradiol in Patients With Hormone Refractory Prostate Cancer

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the antitumor activity, as measured by PSA response rate in patients with hormone and chemotherapy refractory prostate cancer.

Outcome Time Frame:

4 years

Safety Issue:

Yes

Principal Investigator

Mark Stein, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Medicine and Dentistry New Jersey

Authority:

United States: Food and Drug Administration

Study ID:

5247

NCT ID:

NCT00176644

Start Date:

May 2005

Completion Date:

October 2009

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • Prostatic Neoplasms

Name

Location

Morristown Memorial HospitalMorristown, New Jersey  07962-1956
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Overlook HospitalSummit, New Jersey  07902-0220
Saint Peter's University HospitalNew Brunswick, New Jersey  08901-1780
Robert Wood Johnson University Hospital/CINJ at HamiltonHamilton, New Jersey  08690
CentraState Healthcare SystemFreehold, New Jersey  07728