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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00610740
• Other study ID #: 2005LS071
• Secondary ID: WCC #44UMN-0510M
• Status: Completed
• Phase: Phase 2
• First received: February 7, 2008
• Last updated: December 3, 2017
• Start date: July 2006
• Est. completion date: April 2008

Study information

• Verified date: December 2017
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Ovarian Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• topical gemcitabine hydrochloride
Gemcitabine 100 mg/m2 will be administered as a single dose, directly to the cervix via the CerviPrep™ device.

Procedure:
• therapeutic conventional surgery
hysterectomy

Locations

Country	Name	City	State
United States	University of Minnesota Cancer Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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