Trial Outcomes & Findings for Slowed Carboplatin Infusion for Ovarian Cancer Patients Receiving Carboplatin Re-Treatment (NCT NCT02035345)

NCT ID: NCT02035345

Last Updated: 2016-12-08

Results Overview

To determine the frequency of carboplatin infusion hypersensitivity reactions using a slowed carboplatin infusion program

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 15 participants
• Primary outcome timeframe: 2 Years
• Results posted on: 2016-12-08

Participant Flow

Participant milestones

Measure	Carboplatin 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 Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Carboplatin n=15 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Gender Female	15 Participants n=5 Participants
Gender Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 Years

Population: Total number of patients in the study that received carboplatin via slowed infusion.

To determine the frequency of carboplatin infusion hypersensitivity reactions using a slowed carboplatin infusion program

Outcome measures

Measure	Carboplain Slowed Infusion Group Reactors n=15 Participants Patients that received carboplatin via slowed infusion that developed a reaction
Number of Participants With Carboplatin Infusion Hypersensitivity Reactions Using a Slowed Carboplatin Infusion Program	6 participants

PRIMARY outcome

Timeframe: 2 Years

Population: 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.

To characterize the nature and symptoms of carboplatin reactions associated with the slowed infusion protocol.

Outcome measures

Measure	Carboplain Slowed Infusion Group Reactors n=15 Participants Patients that received carboplatin via slowed infusion that developed a reaction
Number of Patients With Carboplatin Reactions of Different Severity Grade 2	3 participants
Number of Patients With Carboplatin Reactions of Different Severity Grade 3	2 participants
Number of Patients With Carboplatin Reactions of Different Severity Grade 4	1 participants

Adverse Events

Carboplatin

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure

Carboplatin n=15 participants at risk 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

Immune system disorders Anaphylaxis

6.7% 1/15 • Number of events 1 • 1 year NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Other adverse events

Measure	Carboplatin n=15 participants at risk 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
Gastrointestinal disorders Vomiting	6.7% 1/15 • Number of events 1 • 1 year NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Immune system disorders Hypersensitivity Reaction	33.3% 5/15 • Number of events 5 • 1 year NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Blood and lymphatic system disorders Hypokalemia	6.7% 1/15 • Number of events 1 • 1 year NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Additional Information

Dr. Aleena Banerji

Massachusetts General Hospital

Phone: 6177263850

Email: abanerji@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place