Trial Outcomes & Findings for CerviPrep for Applying Topical Gemcitabine to the Cervix in Treating Patients With Primary Endometrial, Cervical, or Ovarian Epithelial Cancer (NCT NCT00610740)

Results Overview

Efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix as measured by gemcitabine hydrochloride concentration levels in tissue samples.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

30 Minutes After Application of Gemcitabine

Results posted on

2017-12-28

Participant Flow

5 additional patients were consented, but never treated.

Participant milestones

Participant milestones
Measure	Patients Treated With CerviPrep™ 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 Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Treated With CerviPrep™ n=18 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	50.4 Years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients Treated With CerviPrep™ n=18 Participants 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.
Number of Patients With Measurable Concentration of Gemcitabine in Uterine Vein (dFdC)	5 Participants 8.2

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Patients Treated With CerviPrep™ n=18 Participants 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.
Number of Patients With Measurable Concentration of Gemcitabine Metabolites in Uterine Vein (dFdU)	3 Participants 80.7

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Patients Treated With CerviPrep™ n=18 Participants 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.
Number of Patients With Measurable Peripheral Vein Concentration of dFdC 30 Minutes	0 Participants
Number of Patients With Measurable Peripheral Vein Concentration of dFdC 60 Minutes	0 Participants
Number of Patients With Measurable Peripheral Vein Concentration of dFdC 90 Minutes	0 Participants

Adverse Events

Patients Treated With CerviPrep™

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Patients Treated With CerviPrep™ n=18 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	5.6% 1/18 • Number of events 1 • Day 1 of treatment through 30 Days post treatment

Other adverse events

Adverse event data not reported

Additional Information

Levi Downs, Jr., M.D.

Masonic Cancer Center, University of Minnesota

Phone: 612-626-6628

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place