Trial Outcomes & Findings for Palonosetron Versus Ondansetron for the Prevention of Nausea and Vomiting (NCT NCT01031498)
NCT ID: NCT01031498
Last Updated: 2012-08-07
Results Overview
Number of emesis (vomiting) episodes and no use of rescue medication during the administration of chemotherapy assessed as complete response. Complete response is defined as \< or equal to 1 episode of emesis during entire 7-day study period, no use of of rescue medication during the study period, and no more than moderate nausea (Grade 2, National Cancer Institutes (NCI) Common Terminology Criteria (CTC)) during chemotherapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
150 participants
Primary outcome timeframe
7 days, starting first day of chemotherapy
Results posted on
2012-08-07
Participant Flow
Recruitment Period: 9/13/2005 to 9/22/2009. All patients registered at The University of Texas M.D. Anderson Cancer Center.
Of the 150 enrolled, only 143 patients were evaluable. Two patients were transferred to intensive care unit, two patients did not receive chemotherapy. One patient received one dose and was placed on hold. One patient received two antiemetic drugs; and 1 patient had a severe headache after two doses and was withdrawn.
Participant milestones
| Measure |
Ondansetron: Standard of Care
Standard of care, Ondansetron 8 mg intravenous (IV) as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.
|
Palonosetron Group 1 (5 Days)
Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy.
|
Palonosetron Group 2 (3 Days)
Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy, given over 30 seconds, 30 minutes before chemotherapy.
|
|---|---|---|---|
|
Overall Study
STARTED
|
49
|
51
|
50
|
|
Overall Study
COMPLETED
|
47
|
48
|
48
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Palonosetron Versus Ondansetron for the Prevention of Nausea and Vomiting
Baseline characteristics by cohort
| Measure |
Ondansetron: Standard of Care
n=49 Participants
Standard of care, Ondansetron 8 mg intravenous (IV) as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.
|
Palonosetron Group 1 (5 Days)
n=51 Participants
Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy.
|
Palonosetron Group 2 (3 Days)
n=50 Participants
Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy, given over 30 seconds, 30 minutes before chemotherapy.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
54 years
n=5 Participants
|
52 years
n=7 Participants
|
53 years
n=5 Participants
|
53 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
51 participants
n=7 Participants
|
50 participants
n=5 Participants
|
150 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 7 days, starting first day of chemotherapyPopulation: Analysis was per protocol. Seven patients were excluded from the efficacy analysis.
Number of emesis (vomiting) episodes and no use of rescue medication during the administration of chemotherapy assessed as complete response. Complete response is defined as \< or equal to 1 episode of emesis during entire 7-day study period, no use of of rescue medication during the study period, and no more than moderate nausea (Grade 2, National Cancer Institutes (NCI) Common Terminology Criteria (CTC)) during chemotherapy.
Outcome measures
| Measure |
Ondansetron: Standard of Care
n=47 Participants
Standard of care, Ondansetron 8 mg intravenous (IV) as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.
|
Palonosetron Group 1 (5 Days)
n=48 Participants
Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy.
|
Palonosetron Group 2 (3 Days)
n=48 Participants
Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy, given over 30 seconds, 30 minutes before chemotherapy.
|
|---|---|---|---|
|
Number of Patients With Complete Response
|
11 participants
|
15 participants
|
18 participants
|
Adverse Events
Ondansetron: Standard of Care
Serious events: 6 serious events
Other events: 2 other events
Deaths: 0 deaths
Palonosetron Group 1 (5 Days)
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Palonosetron Group 2 (3 Days)
Serious events: 4 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ondansetron: Standard of Care
n=49 participants at risk
Standard of care, Ondansetron 8 mg intravenous (IV) as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.
|
Palonosetron Group 1 (5 Days)
n=51 participants at risk
Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy.
|
Palonosetron Group 2 (3 Days)
n=50 participants at risk
Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy, given over 30 seconds, 30 minutes before chemotherapy.
|
|---|---|---|---|
|
General disorders
Death
|
4.1%
2/49 • Number of events 2 • 3 years and 7 months
|
0.00%
0/51 • 3 years and 7 months
|
6.0%
3/50 • Number of events 3 • 3 years and 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
6.1%
3/49 • Number of events 3 • 3 years and 7 months
|
2.0%
1/51 • Number of events 1 • 3 years and 7 months
|
2.0%
1/50 • Number of events 1 • 3 years and 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hemorrhage
|
0.00%
0/49 • 3 years and 7 months
|
2.0%
1/51 • Number of events 1 • 3 years and 7 months
|
0.00%
0/50 • 3 years and 7 months
|
|
Renal and urinary disorders
Renal Failure
|
4.1%
2/49 • Number of events 2 • 3 years and 7 months
|
0.00%
0/51 • 3 years and 7 months
|
0.00%
0/50 • 3 years and 7 months
|
|
General disorders
Headache
|
2.0%
1/49 • Number of events 1 • 3 years and 7 months
|
0.00%
0/51 • 3 years and 7 months
|
0.00%
0/50 • 3 years and 7 months
|
|
Cardiac disorders
Hypotension
|
0.00%
0/49 • 3 years and 7 months
|
2.0%
1/51 • Number of events 1 • 3 years and 7 months
|
2.0%
1/50 • Number of events 1 • 3 years and 7 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/49 • 3 years and 7 months
|
0.00%
0/51 • 3 years and 7 months
|
2.0%
1/50 • Number of events 1 • 3 years and 7 months
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/49 • 3 years and 7 months
|
0.00%
0/51 • 3 years and 7 months
|
2.0%
1/50 • Number of events 1 • 3 years and 7 months
|
|
Infections and infestations
Infection Sepsis
|
2.0%
1/49 • Number of events 1 • 3 years and 7 months
|
0.00%
0/51 • 3 years and 7 months
|
0.00%
0/50 • 3 years and 7 months
|
|
Cardiac disorders
Bradycardia
|
2.0%
1/49 • Number of events 1 • 3 years and 7 months
|
2.0%
1/51 • Number of events 1 • 3 years and 7 months
|
0.00%
0/50 • 3 years and 7 months
|
|
Blood and lymphatic system disorders
Alanine Aminotransferase
|
0.00%
0/49 • 3 years and 7 months
|
0.00%
0/51 • 3 years and 7 months
|
2.0%
1/50 • Number of events 1 • 3 years and 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/49 • 3 years and 7 months
|
0.00%
0/51 • 3 years and 7 months
|
2.0%
1/50 • Number of events 1 • 3 years and 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/49 • 3 years and 7 months
|
0.00%
0/51 • 3 years and 7 months
|
2.0%
1/50 • Number of events 1 • 3 years and 7 months
|
|
Infections and infestations
Febrile Neutropenia
|
0.00%
0/49 • 3 years and 7 months
|
0.00%
0/51 • 3 years and 7 months
|
2.0%
1/50 • Number of events 1 • 3 years and 7 months
|
|
Blood and lymphatic system disorders
Hyperbilirubinemia
|
0.00%
0/49 • 3 years and 7 months
|
0.00%
0/51 • 3 years and 7 months
|
2.0%
1/50 • Number of events 1 • 3 years and 7 months
|
Other adverse events
| Measure |
Ondansetron: Standard of Care
n=49 participants at risk
Standard of care, Ondansetron 8 mg intravenous (IV) as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.
|
Palonosetron Group 1 (5 Days)
n=51 participants at risk
Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy.
|
Palonosetron Group 2 (3 Days)
n=50 participants at risk
Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy, given over 30 seconds, 30 minutes before chemotherapy.
|
|---|---|---|---|
|
Gastrointestinal disorders
constipation
|
2.0%
1/49 • Number of events 1 • 3 years and 7 months
|
9.8%
5/51 • Number of events 5 • 3 years and 7 months
|
10.0%
5/50 • Number of events 5 • 3 years and 7 months
|
|
Nervous system disorders
Headache
|
2.0%
1/49 • Number of events 1 • 3 years and 7 months
|
5.9%
3/51 • Number of events 3 • 3 years and 7 months
|
8.0%
4/50 • Number of events 4 • 3 years and 7 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/49 • 3 years and 7 months
|
2.0%
1/51 • Number of events 1 • 3 years and 7 months
|
2.0%
1/50 • Number of events 1 • 3 years and 7 months
|
|
Cardiac disorders
Sinus Bradycardia
|
0.00%
0/49 • 3 years and 7 months
|
0.00%
0/51 • 3 years and 7 months
|
2.0%
1/50 • Number of events 1 • 3 years and 7 months
|
Additional Information
Jorge Cortes, MD / Professor
UT MD Anderson Cancer Center
Phone: 713-745-5783
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place