A Phase II Trial of Climara Transdermal Estradiol in Patients With Hormone Refractory Prostate Cancer
OBJECTIVES:
Primary
- Determine the antitumor activity of transdermal estradiol (Climara^®), as demonstrated
by prostate-specific antigen response, in patients with hormone- and
chemotherapy-refractory metastatic prostate cancer.
Secondary
- Determine the toxic effects of this drug in these patients.
- Determine the measurable disease response in patients treated with this drug.
- Determine time to progression in patients treated with this drug.
- Determine the effect of this drug on testosterone levels in patients with
androgen-resistant disease.
- Determine the quality of life of patients treated with this drug.
OUTLINE: Patients wear 4 transdermal estradiol patches (Climara^®) continuously. All patches
are changed every 7 days. Treatment continues in the absence of disease progression or
unacceptable toxicity.
Quality of life is assessed at baseline, every 3 weeks during study treatment, and at
completion of study treatment.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Decrease of 50% in PSA
No
Mark Stein, MD
Study Chair
Cancer Institute of New Jersey
United States: Federal Government
080419; CDR0000445280
NCT00255632
May 2005
November 2009
Name | Location |
---|---|
Overlook Hospital | Summit, New Jersey 07902-0220 |
Carol G. Simon Cancer Center at Morristown Memorial Hospital | Morristown, New Jersey 07962 |
Cancer Institute of New Jersey at Hamilton | Hamilton, New Jersey 08690 |
Saint Peter's University Hospital | New Brunswick, New Jersey 08901-1780 |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
Mountainside Hospital Cancer Center | Montclair, New Jersey 07042 |
CentraState Medical Center | Freehold, New Jersey 07728 |