Trial Information
Summary: Phase III
Double Blind Clinical Trial Of OvaRex® for Late Stage Ovarian
Cancer, following primary therapy.
Study Description
This study will compare the time to
disease relapse between OvaRex® monoclonal antibody treated
patients and placebo-treated patients. This study will also
compare assessments of survival, quality of life, immune response
and safety between active and placebo groups. A detailed
explanation can be provided by investigators conducting this
trial.
You may be eligible to
participate in this study if you:
- Are female, 18 Years and above
- Have stage III/IV ovarian cancer
- Have had elevated levels of
CA125
- Have had no more than one
debulking surgery
- Have had a complete clinical
response to front-line surgery and chemotherapy
- Patients must have received
chemotherapy that included a platinum compound and a taxane
following appropriate staging procedures; front-line treatment
can include no more than 8 cycles of chemotherapy
- Patients must have had
microscopic or small diameter ( =< 2 cm) residual disease
following primary de-bulking surgical procedure
- Are able to commence this study
within 4-12 weeks of completing last dose of front line
chemotherapy
You are not eligible to
participate in this study if you:
- Have a known allergy to murine
proteins or have had a documented anaphylactic reaction to any
drug, or a known hypersensitivity to diphenhydramine or other
antihistamines of similar chemical structure
- Have had a splenectomy
- Have received other
investigational drugs within 30 days of enrollment
| Contact:
Michelle
Elliot Southwest Regional Cancer Center Located
in: Austin, TX 78705 Telephone: 512-421-4183 Email:
melliot@swrcc.com
|
|
If you would like to learn more
about participating in this study, please send an e-mail message
using the form below.