A Phase II Trial of Climara Transdermal Estradiol in Patients With Hormone Refractory Prostate Cancer
- 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.
- 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
- 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
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.
Masking: Open Label, Primary Purpose: Treatment
Decrease of 50% in PSA
Mark Stein, MD
Cancer Institute of New Jersey
United States: Federal Government
|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|