CerviPrep for Applying Topical Gemcitabine to the Cervix in Treating Patients With Primary Endometrial, Cervical, or Ovarian Epithelial Cancer

December 3, 2017 updated by: Masonic Cancer Center, University of Minnesota

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • To evaluate the efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix

Secondary

  • 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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Diagnosis of primary endometrial or cervical cancer
  • Scheduled to undergo abdominal hysterectomy as part of surgical staging and/or treatment
  • Gynecologic Oncology Group (GOG) performance status 0-2
  • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm³
  • Platelet count ≥ 100,000 cells/mm³
  • Creatinine ≤ 2.5 mg/dL
  • Serum Aspartate aminotransferase (AST) or Alanine transaminase (ALT) ≤ 3 times upper limit of normal
  • Total bilirubin ≤ 2.0 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

Exclusion Criteria:

  • Serious medical condition or psychiatric illness that places the patient at an unacceptable risk for study participation or precludes signing the informed consent
  • Known allergic reaction or hypersensitivity to gemcitabine hydrochloride
  • Prior radiotherapy to the whole abdomen or pelvis
  • More than 28 days since prior standard or experimental anticancer therapy
  • No other concurrent anticancer agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Gemzar
Procedure: therapeutic conventional surgery
hysterectomy
Other Names:
  • removal of uterus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 Minutes After Application of Gemcitabine
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
30 minutes post administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30, 60, 90 minutes post uterine vein sample

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masonic Cancer Center, University of Minnesota

Investigators

  • Principal Investigator: Levi S. Downs, MD, Masonic Cancer Center, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

February 7, 2008

First Submitted That Met QC Criteria

February 7, 2008

First Posted (Estimate)

February 8, 2008

Study Record Updates

Last Update Posted (Actual)

December 28, 2017

Last Update Submitted That Met QC Criteria

December 3, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005LS071
  • WCC #44 (Other Identifier: Women's Cancer Center, University of Minnesota)
  • UMN-0510M6486 (Other Identifier: IRB, University of Minnesota)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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