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

Primary Purpose

Cervical Cancer, Endometrial Cancer, Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
topical gemcitabine hydrochloride
therapeutic conventional surgery
Sponsored by
Masonic Cancer Center, University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring recurrent cervical cancer, cervical cancer, endometrial carcinoma, ovarian epithelial cancer, recurrent ovarian epithelial cancer, recurrent endometrial carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Minnesota Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients Treated with CerviPrep™

Arm 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.

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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

Full Information

First Posted
February 7, 2008
Last Updated
December 3, 2017
Sponsor
Masonic Cancer Center, University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT00610740
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masonic Cancer Center, University of Minnesota

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Endometrial Cancer, Ovarian Cancer
Keywords
recurrent cervical cancer, cervical cancer, endometrial carcinoma, ovarian epithelial cancer, recurrent ovarian epithelial cancer, recurrent endometrial carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients Treated with CerviPrep™
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
topical gemcitabine hydrochloride
Other Intervention Name(s)
Gemzar
Intervention Description
Gemcitabine 100 mg/m2 will be administered as a single dose, directly to the cervix via the CerviPrep™ device.
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Other Intervention Name(s)
removal of uterus
Intervention Description
hysterectomy
Primary Outcome Measure Information:
Title
Number of Patients With Measurable Concentration of Gemcitabine in Uterine Vein (dFdC)
Description
Efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix as measured by gemcitabine hydrochloride concentration levels in tissue samples.
Time Frame
30 Minutes After Application of Gemcitabine
Title
Number of Patients With Measurable Concentration of Gemcitabine Metabolites in Uterine Vein (dFdU)
Description
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
Time Frame
30 minutes post administration
Secondary Outcome Measure Information:
Title
Number of Patients With Measurable Peripheral Vein Concentration of dFdC
Description
Efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix as measured by peripheral gemcitabine hydrochloride concentration levels in blood
Time Frame
30, 60, 90 minutes post uterine vein sample

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Levi S. Downs, MD
Organizational Affiliation
Masonic Cancer Center, University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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