Ovarian Cancer Clinical Trial
Official title:
A Pilot Study Evaluating The Safety Of Avastin And Pelvic Radiation In Women With Pelvic-Confined Recurrence of Gynecological Cancers
This research study is evaluating a drug called avastin in combination with standard radiation as a possible treatment for treatment for recurrent pelvic-confined gynecological cancer (i.e. endometrial, cervical, vulvar, ovarian or vaginal cancers).
The purpose of this research study is to learn the effects (good and bad) of an
antiangiogenic therapy drug (drugs that stop new blood vessel growth and starve a tumor by
cutting off its blood supply) called avastin. Avastin is an antibody directed against
vascular endothelial growth factor, or VEGF. VEGF is a potent, specific growth factor with a
well-defined role in normal and abnormal blood vessel formation. It is present in a wide
variety of normal tissues, but is produced in excess by most solid cancers (tumors). In the
setting of cancer, VEGF promotes the growth of blood vessels that bring nutrients to tumor
cells. In laboratory studies, avastin has been shown to inhibit the growth of several
different types of human cancer cells.
This drug has been studied in at least 3500 people with breast, colorectal, renal, ovarian
and lung cancer. It has not been studied in combination radiation therapy in people with
recurrent gynecological cancer.
Previous clinical trials involving the use of avastin in combination with standard radiation
in colorectal and pancreatic cancer show no significant increase in toxicity as compared to
standard radiation therapy toxicity.
The primary objective of this study is to assess the toxicity of administering avastin with
radiation for recurrent gynecological cancer. The secondary endpoint will be to assess the
time to progression of the disease. This means we hope this treatment program will delay any
regrowth of your cancer as compared to standard therapy with radiotherapy alone. In
addition, how well you respond to the treatment, patterns of remission or recurrence will be
measured.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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