Phase IB/II Study of Phenoxodiol in Patients With Recurrent Ovarian,
Fallopian And Primary Peritoneal Cancer That is Resistant to Second
Line Chemotherapy
I.
Description of Study
A. Purpose
The primary objective of the study is to gain an indication of the
efficacy and safety/tolerability of phenoxodiol when given as a
third-line therapy to patients with advanced, recurrent Ovarian,
Fallopian and Primary Peritoneal Cancer.
B.
Background
Ovarian cancer is the fourth leading cause of cancer related death
in women in the United States. It is the leading cause of cancer
death from gynecologic malignancies. In 2002, it is estimated that
23,300 new cases will be diagnosed in the United States and 13,900
deaths will occur1(Anonymous, 2002. CA Cancer J Clin 52: 23-47.
One out of one hundred women will die from ovarian cancer. The high
mortality is largely related to the absence of early symptoms. Approximately
80% of patients are diagnosed in advanced stages of the disease.
Even in properly diagnosed patients with stage I or II disease,
the five year survival ranges from 50 to 90% depending on the degree
of tumor differentiation. Patients will respond to initial chemotherapy
in 80 – 90% of cases, yet less than 10 – 15% will remain
in remission. Advances in treatment have led to improved five year
survival, approaching 45%, however there have been no advances made
in overall survival. One way to improve survival may be by influencing
the apoptotic pathways.
Phenoxodiol has proven to fulfill these objectives both in vitro
and in vivo.
Information
About The Study
The following documents contain information about the study:
1.
Sample Letter.pdf
2.
Contact Information Form.pdf
The
forms are in pdf format and can be downloaded using Acrobat Reader
Please submit the form and your enquiries to:
Renee Luongo
Section Manager, Gynecologic Oncology
Yale University School of Medicine
Department of OB/GYN
333 Cedar Street
PO Box 208063
New Haven, Connecticut 06520-8063
ATTN: Phenoxodiol Clinical Protocol
Phone: 203-737-5225
Fax: 203-785-6782
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