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

Phase 2

Completed

• Conditions: Endometrial Cancer; Cervical Cancer; Ovarian Cancer
• Interventions: Drug: topical gemcitabine hydrochloride; Procedure: therapeutic conventional surgery

• Registration Number: NCT00610740
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

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 Timeline

• Study Start: 2006-07
• Study First Submitted: 2008-02-07
• Study First Submitted QC: 2008-02-07
• Study First Posted: 2008-02-08
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Results First Submitted: 2010-05-19
• Results First Submitted QC: 2010-05-19
• Results First Posted: 2010-06-17
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-03
• Last Update Posted: 2017-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients Treated with CerviPrep™	topical gemcitabine hydrochloride	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.
Patients Treated with CerviPrep™	therapeutic conventional surgery	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Measurable Peripheral Vein Concentration of dFdC	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

Trial Locations

Locations (1)

University of Minnesota Cancer Center; 🇺🇸 Minneapolis, Minnesota, United States