Trial Outcomes & Findings for Fat Emulsion in Preventing Hypersensitivity Reactions in Patients With Cancer Receiving Carboplatin or Oxaliplatin (NCT NCT03122886)
NCT ID: NCT03122886
Last Updated: 2024-12-17
Results Overview
The primary endpoint is the time to healthcare provider reported hypersensitivity reactions from either carboplatin or oxaliplatin. Kaplan Meier curves will be constructed and a log-rank test will be used to compare time-to-hypersensitivity reaction between treatment arms. Data will be censored based on last infusion with no hypersensitivity reaction with a maximum study treatment duration of 2 years per patient.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2024-12-17
Participant Flow
Participant milestones
| Measure |
Group I (Fat Emulsion)
Patients receive fat emulsion IV immediately before each dose of either carboplatin or oxaliplatin. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Group II (Placebo)
Patients receive placebo IV immediately before each dose of either carboplatin or oxaliplatin. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
|
Overall Study
COMPLETED
|
9
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Group I (Fat Emulsion)
Patients receive fat emulsion IV immediately before each dose of either carboplatin or oxaliplatin. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Group II (Placebo)
Patients receive placebo IV immediately before each dose of either carboplatin or oxaliplatin. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
Fat Emulsion in Preventing Hypersensitivity Reactions in Patients With Cancer Receiving Carboplatin or Oxaliplatin
Baseline characteristics by cohort
| Measure |
Group I (Fat Emulsion)
n=10 Participants
Patients receive fat emulsion IV immediately before each dose of either carboplatin or oxaliplatin. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Group II (Placebo)
n=9 Participants
Patients receive placebo IV immediately before each dose of either carboplatin or oxaliplatin. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.5 years
n=5 Participants
|
66 years
n=7 Participants
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
ECOG Performance Status
0
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
ECOG Performance Status
1
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: Evaluable participants are included in this analysis (i.e. exclude Withdrawals).
The primary endpoint is the time to healthcare provider reported hypersensitivity reactions from either carboplatin or oxaliplatin. Kaplan Meier curves will be constructed and a log-rank test will be used to compare time-to-hypersensitivity reaction between treatment arms. Data will be censored based on last infusion with no hypersensitivity reaction with a maximum study treatment duration of 2 years per patient.
Outcome measures
| Measure |
Group I (Fat Emulsion)
n=9 Participants
Patients receive fat emulsion IV immediately before each dose of either carboplatin or oxaliplatin. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Group II (Placebo)
n=7 Participants
Patients receive placebo IV immediately before each dose of either carboplatin or oxaliplatin. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Time-to-carboplatin or Oxaliplatin Acute Hypersensitivity Reaction
|
4.4 months
Interval 1.4 to 4.4
|
NA months
Interval 2.8 to
The median and 95% confidence interval upper limit was not evaluable (i.e. insufficient number of events observed to ascertain these summary statistics).
|
Adverse Events
Group I (Fat Emulsion)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Group II (Placebo)
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group I (Fat Emulsion)
n=9 participants at risk
Patients receive fat emulsion IV immediately before each dose of either carboplatin or oxaliplatin. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Group II (Placebo)
n=7 participants at risk
Patients receive placebo IV immediately before each dose of either carboplatin or oxaliplatin. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/9 • Up to 2 years
Evaluable participants are included in this analysis (i.e. exclude Withdrawals).
|
14.3%
1/7 • Number of events 1 • Up to 2 years
Evaluable participants are included in this analysis (i.e. exclude Withdrawals).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/9 • Up to 2 years
Evaluable participants are included in this analysis (i.e. exclude Withdrawals).
|
14.3%
1/7 • Number of events 1 • Up to 2 years
Evaluable participants are included in this analysis (i.e. exclude Withdrawals).
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
0.00%
0/9 • Up to 2 years
Evaluable participants are included in this analysis (i.e. exclude Withdrawals).
|
14.3%
1/7 • Number of events 1 • Up to 2 years
Evaluable participants are included in this analysis (i.e. exclude Withdrawals).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
1/9 • Number of events 1 • Up to 2 years
Evaluable participants are included in this analysis (i.e. exclude Withdrawals).
|
0.00%
0/7 • Up to 2 years
Evaluable participants are included in this analysis (i.e. exclude Withdrawals).
|
Other adverse events
| Measure |
Group I (Fat Emulsion)
n=9 participants at risk
Patients receive fat emulsion IV immediately before each dose of either carboplatin or oxaliplatin. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Group II (Placebo)
n=7 participants at risk
Patients receive placebo IV immediately before each dose of either carboplatin or oxaliplatin. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Immune system disorders
Allergic reaction
|
33.3%
3/9 • Number of events 3 • Up to 2 years
Evaluable participants are included in this analysis (i.e. exclude Withdrawals).
|
14.3%
1/7 • Number of events 1 • Up to 2 years
Evaluable participants are included in this analysis (i.e. exclude Withdrawals).
|
|
Investigations
Alkaline phosphatase increased
|
22.2%
2/9 • Number of events 4 • Up to 2 years
Evaluable participants are included in this analysis (i.e. exclude Withdrawals).
|
14.3%
1/7 • Number of events 1 • Up to 2 years
Evaluable participants are included in this analysis (i.e. exclude Withdrawals).
|
|
Investigations
Aspartate aminotransferase increased
|
11.1%
1/9 • Number of events 1 • Up to 2 years
Evaluable participants are included in this analysis (i.e. exclude Withdrawals).
|
0.00%
0/7 • Up to 2 years
Evaluable participants are included in this analysis (i.e. exclude Withdrawals).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place