ClinicalTrials.gov
ClinicalTrials.gov Menu

WCC# 59 Hyperthermic Intraperitoneal Chemotherapy Utilizing Carboplatin in First Recurrence Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01144442
Recruitment Status : Completed
First Posted : June 15, 2010
Results First Posted : September 5, 2013
Last Update Posted : March 25, 2016
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: Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Carcinoma
Interventions: Drug: Hyperthermic intraperitoneal chemotherapy with Carboplatin
Other: Isotonic saline (perfusate)
Procedure: Surgery
Drug: Carboplatin
Drug: Paclitaxel

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Women were recruited from the Women's Health Clinic at the University of Minnesota. Recruitment occurred from September 2010 to April 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Once subjects signed consent, they underwent cytoreductive surgery by a gynecologic oncologist with intent to resect all visible cancer. If subjects did not achieve optimal cytoreduction, they were ineligible.

Reporting Groups
  Description
HIPC Treatment Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.

Participant Flow:   Overall Study
    HIPC Treatment
STARTED   10 
COMPLETED   10 
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
HIPC Treatment Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.

Baseline Measures
   HIPC Treatment 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   9 
>=65 years   1 
Age, Customized 
[Units: Years]
Median (Full Range)
 56 
 (47 to 66) 
Gender 
[Units: Participants]
 
Female   10 
Male   0 
Region of Enrollment 
[Units: Participants]
 
United States   10 


  Outcome Measures

1.  Primary:   Clinical Response   [ Time Frame: After 6 cycles of Paclitaxel & Carboplatin (Week 21 up to 27) ]

2.  Primary:   Feasibility of HIPC in Recurrent Disease Setting   [ Time Frame: 6 months ]

3.  Secondary:   Quality of Life Measurements   [ Time Frame: Baseline, 6 Weeks Post Surgery, Every 3 Weeks Up to Week 27 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Progression-free Survival   [ Time Frame: Up to 5 Years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Overall Survival   [ Time Frame: Up to 5 Years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
The primary weakness of this study is the small sample size.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Peter Argenta, MD
Organization: Masonic Cancer Center
phone: 612-626-3111
e-mail: argenta@umn.edu



Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT01144442     History of Changes
Other Study ID Numbers: 2009LS114
WCC# 59 ( Other Identifier: Women's Cancer Center, University of Minnesota )
1003M78874 ( Other Identifier: IRB, University of Minnesota )
First Submitted: May 26, 2010
First Posted: June 15, 2010
Results First Submitted: June 25, 2013
Results First Posted: September 5, 2013
Last Update Posted: March 25, 2016