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

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ClinicalTrials.gov Identifier: NCT00610740
Recruitment Status : Completed
First Posted : February 8, 2008
Results First Posted : June 17, 2010
Last Update Posted : December 28, 2017
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cervical Cancer
Endometrial Cancer
Ovarian Cancer
Interventions Drug: topical gemcitabine hydrochloride
Procedure: therapeutic conventional surgery
Enrollment 18
Recruitment Details 5 additional patients were consented, but never treated.
Pre-assignment Details  
Arm/Group Title Patients Treated With CerviPrep™
Hide Arm/Group Description During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m^2 using CerviPrep™ drug delivery system. 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.
Period Title: Overall Study
Started 18
Completed 18
Not Completed 0
Arm/Group Title Patients Treated With CerviPrep™
Hide Arm/Group Description During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m^2 using CerviPrep™ drug delivery system. 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.
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<=18 years
0
   0.0%
Between 18 and 65 years
18
 100.0%
>=65 years
0
   0.0%
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
50.4  (11.1)
[1]
Measure Description: All 23 patients are included in this measure - only 18 participated and were treated.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
18
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
1.Primary Outcome
Title Number of Patients With Measurable Concentration of Gemcitabine in Uterine Vein (dFdC)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Treated With CerviPrep™
Hide Arm/Group Description:
During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m^2 using CerviPrep™ drug delivery system. 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.
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: Participants
5
2.Primary Outcome
Title Number of Patients With Measurable Concentration of Gemcitabine Metabolites in Uterine Vein (dFdU)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Treated With CerviPrep™
Hide Arm/Group Description:
During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m^2 using CerviPrep™ drug delivery system. 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.
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: Participants
3
3.Secondary Outcome
Title Number of Patients With Measurable Peripheral Vein Concentration of dFdC
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Treated With CerviPrep™
Hide Arm/Group Description:
During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m^2 using CerviPrep™ drug delivery system. 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.
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: Participants
30 Minutes 0
60 Minutes 0
90 Minutes 0
Time Frame Day 1 of treatment through 30 Days post treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patients Treated With CerviPrep™
Hide Arm/Group Description During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m^2 using CerviPrep™ drug delivery system. 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.
All-Cause Mortality
Patients Treated With CerviPrep™
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Patients Treated With CerviPrep™
Affected / at Risk (%) # Events
Total   1/18 (5.56%)    
Respiratory, thoracic and mediastinal disorders   
Acute respiratory distress syndrome  1  1/18 (5.56%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Patients Treated With CerviPrep™
Affected / at Risk (%) # Events
Total   0/18 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Levi Downs, Jr., M.D.
Organization: Masonic Cancer Center, University of Minnesota
Phone: 612-626-6628
Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00610740     History of Changes
Other Study ID Numbers: 2005LS071
WCC #44 ( Other Identifier: Women's Cancer Center, University of Minnesota )
UMN-0510M6486 ( Other Identifier: IRB, University of Minnesota )
First Submitted: February 7, 2008
First Posted: February 8, 2008
Results First Submitted: May 19, 2010
Results First Posted: June 17, 2010
Last Update Posted: December 28, 2017