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Trial record 20 of 163 for:    ovarian cancer and Minnesota

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):

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
5 additional patients were consented, but never treated.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Patients Treated With CerviPrep™
STARTED   18 
COMPLETED   18 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Baseline Measures
   Patients Treated With CerviPrep™ 
Overall Participants Analyzed 
[Units: Participants]
 18 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      18 100.0% 
>=65 years      0   0.0% 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 50.4  (11.1) 
[1] All 23 patients are included in this measure - only 18 participated and were treated.
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      18 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   18 


  Outcome Measures

1.  Primary:   Number of Patients With Measurable Concentration of Gemcitabine in Uterine Vein (dFdC)   [ Time Frame: 30 Minutes After Application of Gemcitabine ]

2.  Primary:   Number of Patients With Measurable Concentration of Gemcitabine Metabolites in Uterine Vein (dFdU)   [ Time Frame: 30 minutes post administration ]

3.  Secondary:   Number of Patients With Measurable Peripheral Vein Concentration of dFdC   [ Time Frame: 30, 60, 90 minutes post uterine vein sample ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: downs008@umn.edu



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