CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
topical gemcitabine hydrochloride +1 moredrug
Likely dose
topical gemcitabine hydrochloride 100 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00610740
NCT00610740Phase 2Completed
CompareCT.gov

WCC# 44: A Pilot Study of CerviPrep, a Novel Drug Delivery Device for the Cervix, in the Local Administration of Gemcitabine, a Radiation Sensitizer

Masonic Cancer Center, University of Minnesota·interventional·Posted Feb 8, 2008·Updated Dec 28, 2017

In Brief

A Phase 2 clinical trial evaluating topical gemcitabine hydrochloride and therapeutic conventional surgery for Cervical Cancer and 2 related conditions. Completed, enrolled 18 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Cancer, Endometrial Cancer, Ovarian Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 8, 2008
Enrollment StartJul 1, 2006
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.4 years ago

Interventions

topical gemcitabine hydrochloridedrug

Gemcitabine 100 mg/m2 will be administered as a single dose, directly to the cervix via the CerviPrep™ device.

therapeutic conventional surgeryprocedure

hysterectomy