CerviPrep for Applying Topical Gemcitabine to the Cervix in Treating Patients With Primary Endometrial, Cervical, or Ovarian Epithelial Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Using the CerviPrep™ drug delivery device to apply topical gemcitabine to the cervix may be an effective way to kill more tumor cells.
PURPOSE: This phase II trial is studying how well CerviPrep™ works in applying topical gemcitabine to the cervix in treating patients with primary endometrial cancer, cervical cancer, or ovarian epithelial cancer.
Drug: topical gemcitabine hydrochloride
Procedure: therapeutic conventional surgery
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||WCC# 44: A Pilot Study of CerviPrep, a Novel Drug Delivery Device for the Cervix, in the Local Administration of Gemcitabine, a Radiation Sensitizer|
- Number of Patients With Measurable Concentration of Gemcitabine in Uterine Vein (dFdC) [ Time Frame: 30 Minutes After Application of Gemcitabine ]Efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix as measured by gemcitabine hydrochloride concentration levels in tissue samples.
- Number of Patients With Measurable Concentration of Gemcitabine Metabolites in Uterine Vein (dFdU) [ Time Frame: 30 minutes post administration ]Efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix as measured by local (uterine vein) gemcitabine hydrochloride concentration levels in blood
- Number of Patients With Measurable Peripheral Vein Concentration of dFdC [ Time Frame: 30, 60, 90 minutes post uterine vein sample ]Efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix as measured by peripheral gemcitabine hydrochloride concentration levels in blood
|Study Start Date:||July 2006|
|Study Completion Date:||April 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Experimental: Patients Treated with CerviPrep™
CerviPrep™, a novel drug delivery device, was developed specifically for applying pharmaceuticals directly on the cervix. It consists of a syringe-like tube attached to a plastic cap that covers the cervix. Drug can be delivered through the tube, directly to the cervix without spillage onto vaginal or vulvar tissues.
Drug: topical gemcitabine hydrochloride
Gemcitabine 100 mg/m2 will be administered as a single dose, directly to the cervix via the CerviPrep™ device.
Other Name: GemzarProcedure: therapeutic conventional surgery
Other Name: removal of uterus
- 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 hydrochloride.
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 gemcitabine hydrochloride.
After completion of study therapy, patients are followed at 2-4 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00610740
|United States, Minnesota|
|University of Minnesota Cancer Center|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Levi S. Downs, MD||Masonic Cancer Center, University of Minnesota|