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

Brief Title

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

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

Brief 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.

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 Phase

Phase 2

Study Type

Interventional

Primary Outcome

Number of Patients With Measurable Concentration of Gemcitabine in Uterine Vein (dFdC)

Secondary Outcome

 Number of Patients With Measurable Peripheral Vein Concentration of dFdC

Condition

Cervical Cancer

Intervention

topical gemcitabine hydrochloride

Study Arms / Comparison Groups

 Patients Treated with CerviPrep™

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

July 2006

Completion Date

April 2008

Primary Completion Date

April 2008

Eligibility Criteria

        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

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Levi S. Downs, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00610740

Organization ID

2005LS071

Secondary IDs

WCC #44

Responsible Party

Sponsor

Study Sponsor

Masonic Cancer Center, University of Minnesota

Study Sponsor

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

Verification Date

December 2017