WCC# 44: A Pilot Study of CerviPrep, a Novel Drug Delivery Device for the Cervix, in the Local Administration of Gemcitabine, a Radiation Sensitizer
- To evaluate the efficacy of the CerviPrep™ device in delivering topical gemcitabine
hydrochloride to the cervix
- To document any side effects directly attributed to local administration of gemcitabine
OUTLINE: Patients undergo application of topical gemcitabine hydrochloride directly to the
cervix using the CerviPrep™ drug delivery device during routine hysterectomy.
Uterine vein and peripheral blood samples are obtained periodically to measure local and
peripheral gemcitabine hydrochloride concentration levels in the blood. Local gemcitabine
hydrochloride concentration levels are also measured in uterine tissue samples obtained from
the surgical specimen after hysterectomy.
Patients complete a self-reported symptom diary for the first 7 days after surgery for
assessment of local and systemic side effects associated with topical administration of
After completion of study therapy, patients are followed at 2-4 weeks.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients With Measurable Concentration of Gemcitabine in Uterine Vein (dFdC)
Efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix as measured by gemcitabine hydrochloride concentration levels in tissue samples.
30 Minutes After Application of Gemcitabine
Levi S. Downs, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|University of Minnesota Cancer Center||Minneapolis, Minnesota 55455|