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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervical Cancer, Endometrial Cancer, Ovarian Cancer

Intervention / Treatment
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* Drug: topical gemcitabine hydrochloride
* Procedure: therapeutic conventional surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients Treated with CerviPrep™<br>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<br>* Gemcitabine 100 mg/m2 will be administered as a single dose, directly to the cervix via the CerviPrep™ device.<br>* Other names: Gemzar;Procedure: therapeutic conventional surgery<br>* hysterectomy<br>* Other names: removal of uterus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Measurable Concentration of Gemcitabine in Uterine Vein (dFdC) | 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) | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent cervical cancer, cervical cancer, endometrial carcinoma, ovarian epithelial cancer, recurrent ovarian epithelial cancer, recurrent endometrial carcinoma