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

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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
Enrollment 10
Recruitment Details 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 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.
Arm/Group Title HIPC Treatment
Hide Arm/Group Description Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title HIPC Treatment
Hide Arm/Group Description Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
9
  90.0%
>=65 years
1
  10.0%
Age, Customized  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants
56
(47 to 66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
10
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Clinical Response
Hide Description We will summarize clinical response as the proportion of patients with complete response. Complete response will be defined as normalization of CA125. - After 6 cycles of Second Line Adjuvant Chemotherapy.
Time Frame After 6 cycles of Paclitaxel & Carboplatin (Week 21 up to 27)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIPC Treatment
Hide Arm/Group Description:
Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
10
2.Primary Outcome
Title Feasibility of HIPC in Recurrent Disease Setting
Hide Description We will determine feasibility based on the proportion of patients who complete 6 prescribed cycles of second line chemotherapy after undergoing the HIPC procedure.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIPC Treatment
Hide Arm/Group Description:
Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
9
3.Secondary Outcome
Title Quality of Life Measurements
Hide Description The quality of life measurements (version 4 of the FACT-O questionnaire) will be summed over each subscale and overall and comparisons will be made using t-tests at distinct visits.
Time Frame Baseline, 6 Weeks Post Surgery, Every 3 Weeks Up to Week 27
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Progression-free Survival
Hide Description Disease progression will be defined as time from surgery to first of either an increase in CA125 from post-treatment value (to a value greater than 100 or doubling of nadir CA125 levels) or new/increasing measurable disease by CT scan as defined by RECIST criteria, (secondary recurrence) or censored at date of last contact for patients still alive and who have no progressed or recurred (from date of surgery to disease progression).
Time Frame Up to 5 Years
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Overall Survival
Hide Description Overall survival will be defined as time from date of surgery to date of death or censored at the date of last documented contact for patients still alive.
Time Frame Up to 5 Years
Outcome Measure Data Not Reported
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title HIPC Treatment
Hide Arm/Group Description Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
All-Cause Mortality
HIPC Treatment
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
HIPC Treatment
Affected / at Risk (%) # Events
Total   2/10 (20.00%)    
Blood and lymphatic system disorders   
Pancytopenia  1 [1]  1/10 (10.00%)  1
Febrile neutropenia  1 [2]  1/10 (10.00%)  1
Investigations   
Platelet count decreased  1 [2]  1/10 (10.00%)  1
Renal and urinary disorders   
Acute Kidney Injury  1 [1]  1/10 (10.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
[1]
Grade 3
[2]
Grade 4
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
HIPC Treatment
Affected / at Risk (%) # Events
Total   10/10 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  2/10 (20.00%)  2
Neutropenia  1  3/10 (30.00%)  3
Thrombocytopenia  1  2/10 (20.00%)  2
Gastrointestinal disorders   
Nausea  1  6/10 (60.00%)  6
Ileus  1  2/10 (20.00%)  2
Hepatobiliary disorders   
Transaminase abnormalties  1  1/10 (10.00%)  1
Metabolism and nutrition disorders   
Hypokalemia  1  3/10 (30.00%)  3
Hypocalcemia  1  2/10 (20.00%)  2
Acidosis  1  1/10 (10.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
The primary weakness of this study is the small sample size.
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
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