Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Slowed Carboplatin Infusion for Ovarian Cancer Patients Receiving Carboplatin Re-Treatment

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: NCT02035345
Recruitment Status : Terminated (Extended Carboplatin Infusion did not Reduce Frequency of Hypersensitivity Reactions)
First Posted : January 14, 2014
Results First Posted : November 1, 2016
Last Update Posted : December 8, 2016
Sponsor:
Information provided by (Responsible Party):
Aleena Banerji, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Recurrent Ovarian Cancer
Platinum Sensitive Ovarian Cancer
Intervention Drug: Carboplatin
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Carboplatin
Hide Arm/Group Description

Carboplatin will be prepared as a single 500ml infusion. Potentially 6 cycles Carboplatin (Amount of total dose) will be administered intravenously by the treating nurse according to the following schedule:

  • First hour - Administer 1 percent of total dose (5ml with tubing primed)
  • Second hour - Administer 9 percent (45 mL)
  • Third hour - Administer 90 percent (450 mL)

Carboplatin

Period Title: Overall Study
Started 15
Completed 15
Not Completed 0
Arm/Group Title Carboplatin
Hide Arm/Group Description

Carboplatin will be prepared as a single 500ml infusion. Potentially 6 cycles Carboplatin (Amount of total dose) will be administered intravenously by the treating nurse according to the following schedule:

  • First hour - Administer 1 percent of total dose (5ml with tubing primed)
  • Second hour - Administer 9 percent (45 mL)
  • Third hour - Administer 90 percent (450 mL)

Carboplatin

Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
  46.7%
>=65 years
8
  53.3%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
15
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Hispanic or Latino
1
   6.7%
Not Hispanic or Latino
13
  86.7%
Unknown or Not Reported
1
   6.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
13
  86.7%
More than one race
0
   0.0%
Unknown or Not Reported
2
  13.3%
1.Primary Outcome
Title Number of Participants With Carboplatin Infusion Hypersensitivity Reactions Using a Slowed Carboplatin Infusion Program
Hide Description To determine the frequency of carboplatin infusion hypersensitivity reactions using a slowed carboplatin infusion program
Time Frame 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Total number of patients in the study that received carboplatin via slowed infusion.
Arm/Group Title Carboplain Slowed Infusion Group Reactors
Hide Arm/Group Description:
Patients that received carboplatin via slowed infusion that developed a reaction
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
6
2.Primary Outcome
Title Number of Patients With Carboplatin Reactions of Different Severity
Hide Description To characterize the nature and symptoms of carboplatin reactions associated with the slowed infusion protocol.
Time Frame 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Among the 15 patients enrolled, the HSR rate was 40% which occurred after a median of 2 protocol treatments, which prompted early termination of this study.
Arm/Group Title Carboplatin
Hide Arm/Group Description:

Carboplatin will be prepared as a single 500ml infusion. Potentially 6 cycles Carboplatin (Amount of total dose) will be administered intravenously by the treating nurse according to the following schedule:

  • First hour - Administer 1 percent of total dose (5ml with tubing primed)
  • Second hour - Administer 9 percent (45 mL)
  • Third hour - Administer 90 percent (450 mL)

Carboplatin

Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
Grade 2 3
Grade 3 2
Grade 4 1
Time Frame 1 year
Adverse Event Reporting Description NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
 
Arm/Group Title Carboplatin
Hide Arm/Group Description

Carboplatin will be prepared as a single 500ml infusion. Potentially 6 cycles Carboplatin (Amount of total dose) will be administered intravenously by the treating nurse according to the following schedule:

  • First hour - Administer 1 percent of total dose (5ml with tubing primed)
  • Second hour - Administer 9 percent (45 mL)
  • Third hour - Administer 90 percent (450 mL)

Carboplatin

All-Cause Mortality
Carboplatin
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Carboplatin
Affected / at Risk (%) # Events
Total   1/15 (6.67%)    
Immune system disorders   
Anaphylaxis  1 [1]  1/15 (6.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
[1]
Anaphylaxis is considered a serious adverse event (or very severe hypersensitivity reaction)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Carboplatin
Affected / at Risk (%) # Events
Total   6/15 (40.00%)    
Blood and lymphatic system disorders   
Hypokalemia  1  1/15 (6.67%)  1
Gastrointestinal disorders   
Vomiting  1  1/15 (6.67%)  1
Immune system disorders   
Hypersensitivity Reaction  1  5/15 (33.33%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Aleena Banerji
Organization: Massachusetts General Hospital
Phone: 6177263850
EMail: abanerji@mgh.harvard.edu
Layout table for additonal information
Responsible Party: Aleena Banerji, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02035345    
Other Study ID Numbers: 13-413
First Submitted: November 21, 2013
First Posted: January 14, 2014
Results First Submitted: August 30, 2016
Results First Posted: November 1, 2016
Last Update Posted: December 8, 2016