Trial Outcomes & Findings for Prevention of Delayed Nausea A Phase III Double-Blind Placebo-Controlled Clinical Trial (NCT NCT00475085)
NCT ID: NCT00475085
Last Updated: 2015-11-10
Results Overview
1=not at all nauseated to 7=extremely nauseated, therefore higher values are worse
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1021 participants
Primary outcome timeframe
average of day 1 afternoon, evening and night, and all of days 2 and 3
Results posted on
2015-11-10
Participant Flow
Patients from 15 private-practice oncology groups in the USA affiliated with the University of Rochester Cancer Center Community Clinical Oncology Program (URCC CCOP)were enrolled by research personnel from May 2007 to September 2010.
Participant milestones
| Measure |
Arm 1 Palonosetron, Dexamethasone, Compazine
Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.
placebo : Given orally
prochlorperazine : Given orally or IV
palonosetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV
|
Arm 2 Granisetron, Dexamethasone, Compazine
Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
placebo : Given orally
prochlorperazine : Given orally or IV
granisetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV
|
Arm 3 Aprepitant, Palonosetron, Dexamethasone
Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.
placebo : Given orally
aprepitant : Given orally or IV
palonosetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV
|
Arm 4 Palonosetron, Dexamethasone, Compazine, Dexamethasone
Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
placebo : Given orally
prochlorperazine : Given orally or IV
palonosetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
253
|
254
|
260
|
254
|
|
Overall Study
COMPLETED
|
235
|
234
|
241
|
234
|
|
Overall Study
NOT COMPLETED
|
18
|
20
|
19
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prevention of Delayed Nausea A Phase III Double-Blind Placebo-Controlled Clinical Trial
Baseline characteristics by cohort
| Measure |
Arm II
n=254 Participants
Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
placebo : Given orally
prochlorperazine : Given orally or IV
granisetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV
|
Arm III
n=260 Participants
Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.
placebo : Given orally
aprepitant : Given orally or IV
palonosetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV
|
Arm I
n=254 Participants
Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
placebo : Given orally
prochlorperazine : Given orally or IV
palonosetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV
|
Arm IV
n=253 Participants
Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.
placebo : Given orally
prochlorperazine : Given orally or IV
palonosetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV
|
Total
n=1021 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
57.2 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
58.6 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
57.1 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
58.2 years
STANDARD_DEVIATION 11.4 • n=4 Participants
|
57.8 years
STANDARD_DEVIATION 12.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
208 Participants
n=5 Participants
|
201 Participants
n=7 Participants
|
193 Participants
n=5 Participants
|
208 Participants
n=4 Participants
|
810 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
211 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 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
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
85 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
232 Participants
n=5 Participants
|
226 Participants
n=7 Participants
|
231 Participants
n=5 Participants
|
229 Participants
n=4 Participants
|
918 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
254 participants
n=5 Participants
|
260 participants
n=7 Participants
|
254 participants
n=5 Participants
|
253 participants
n=4 Participants
|
1021 participants
n=21 Participants
|
|
Previous Surgery
|
193 participants
n=5 Participants
|
194 participants
n=7 Participants
|
196 participants
n=5 Participants
|
198 participants
n=4 Participants
|
781 participants
n=21 Participants
|
|
Previous Radiotherapy
|
6 participants
n=5 Participants
|
12 participants
n=7 Participants
|
12 participants
n=5 Participants
|
9 participants
n=4 Participants
|
39 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: average of day 1 afternoon, evening and night, and all of days 2 and 31=not at all nauseated to 7=extremely nauseated, therefore higher values are worse
Outcome measures
| Measure |
Arm II
n=234 Participants
Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
placebo : Given orally
prochlorperazine : Given orally or IV
granisetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV
|
Arm III
n=241 Participants
Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.
placebo : Given orally
aprepitant : Given orally or IV
palonosetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV
|
Arm I
n=234 Participants
Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
placebo : Given orally
prochlorperazine : Given orally or IV
palonosetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV
|
Arm IV
n=235 Participants
Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.
placebo : Given orally
prochlorperazine : Given orally or IV
palonosetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV
|
|---|---|---|---|---|
|
Home Record: Severity of Delayed Nausea
|
1.88 units on a scale
Standard Deviation 1.27
|
1.65 units on a scale
Standard Deviation 1.15
|
1.87 units on a scale
Standard Deviation 1.20
|
1.68 units on a scale
Standard Deviation 1.15
|
Adverse Events
Arm II
Serious events: 6 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm III
Serious events: 17 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm I
Serious events: 16 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm IV
Serious events: 11 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm II
Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
placebo : Given orally
prochlorperazine : Given orally or IV
granisetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV
|
Arm III
Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.
placebo : Given orally
aprepitant : Given orally or IV
palonosetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV
|
Arm I
Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
placebo : Given orally
prochlorperazine : Given orally or IV
palonosetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV
|
Arm IV
Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.
placebo : Given orally
prochlorperazine : Given orally or IV
palonosetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphoma
|
0.39%
1/254 • Number of events 1
|
0.00%
0/260
|
0.00%
0/254
|
0.00%
0/253
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/254
|
1.2%
3/260 • Number of events 3
|
0.39%
1/254 • Number of events 1
|
0.00%
0/253
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/254
|
0.38%
1/260 • Number of events 1
|
0.00%
0/254
|
0.00%
0/253
|
|
Blood and lymphatic system disorders
Trombocytopenia
|
0.00%
0/254
|
0.00%
0/260
|
0.39%
1/254 • Number of events 1
|
0.00%
0/253
|
|
Gastrointestinal disorders
Gastrointestinal
|
0.39%
1/254 • Number of events 1
|
1.2%
3/260 • Number of events 3
|
0.00%
0/254
|
1.2%
3/253 • Number of events 3
|
|
Gastrointestinal disorders
GI Bleed
|
0.00%
0/254
|
0.00%
0/260
|
0.00%
0/254
|
0.40%
1/253 • Number of events 1
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
0.39%
1/254 • Number of events 1
|
0.38%
1/260 • Number of events 1
|
0.39%
1/254 • Number of events 1
|
1.2%
3/253 • Number of events 4
|
|
General disorders
Chest Pain
|
0.00%
0/254
|
0.38%
1/260 • Number of events 1
|
0.00%
0/254
|
0.40%
1/253 • Number of events 1
|
|
General disorders
Dehydration
|
0.00%
0/254
|
0.38%
1/260 • Number of events 1
|
0.00%
0/254
|
0.00%
0/253
|
|
General disorders
Edema
|
0.00%
0/254
|
0.38%
1/260 • Number of events 1
|
0.00%
0/254
|
0.00%
0/253
|
|
General disorders
Fatigue
|
0.00%
0/254
|
0.38%
1/260 • Number of events 1
|
0.00%
0/254
|
0.00%
0/253
|
|
General disorders
Headache
|
0.39%
1/254 • Number of events 1
|
0.00%
0/260
|
0.79%
2/254 • Number of events 2
|
0.00%
0/253
|
|
General disorders
Migraine
|
0.00%
0/254
|
0.00%
0/260
|
0.00%
0/254
|
0.40%
1/253 • Number of events 2
|
|
General disorders
Restless
|
0.00%
0/254
|
0.00%
0/260
|
0.39%
1/254 • Number of events 1
|
0.00%
0/253
|
|
Immune system disorders
Allergic Reaction
|
0.00%
0/254
|
0.77%
2/260 • Number of events 2
|
0.39%
1/254 • Number of events 1
|
0.00%
0/253
|
|
Infections and infestations
Infection
|
0.00%
0/254
|
0.00%
0/260
|
0.79%
2/254 • Number of events 2
|
0.00%
0/253
|
|
Infections and infestations
MRSA
|
0.00%
0/254
|
0.00%
0/260
|
0.39%
1/254 • Number of events 1
|
0.00%
0/253
|
|
Injury, poisoning and procedural complications
Infusion Reaction
|
0.00%
0/254
|
0.00%
0/260
|
0.39%
1/254 • Number of events 1
|
0.00%
0/253
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/254
|
0.00%
0/260
|
0.39%
1/254 • Number of events 1
|
0.00%
0/253
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/254
|
0.00%
0/260
|
0.39%
1/254 • Number of events 1
|
0.00%
0/253
|
|
Renal and urinary disorders
Renal Failure
|
0.39%
1/254 • Number of events 1
|
0.38%
1/260 • Number of events 1
|
0.00%
0/254
|
0.40%
1/253 • Number of events 1
|
|
Reproductive system and breast disorders
Hydrocele
|
0.00%
0/254
|
0.00%
0/260
|
0.39%
1/254 • Number of events 1
|
0.00%
0/253
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
0.00%
0/254
|
0.38%
1/260 • Number of events 1
|
0.00%
0/254
|
0.00%
0/253
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/254
|
0.38%
1/260 • Number of events 1
|
0.79%
2/254 • Number of events 2
|
0.00%
0/253
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.39%
1/254 • Number of events 1
|
0.00%
0/260
|
0.00%
0/254
|
0.00%
0/253
|
|
Vascular disorders
Hemorrhage
|
0.00%
0/254
|
0.00%
0/260
|
0.00%
0/254
|
0.40%
1/253 • Number of events 1
|
Other adverse events
| Measure |
Arm II
Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
placebo : Given orally
prochlorperazine : Given orally or IV
granisetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV
|
Arm III
Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.
placebo : Given orally
aprepitant : Given orally or IV
palonosetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV
|
Arm I
Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
placebo : Given orally
prochlorperazine : Given orally or IV
palonosetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV
|
Arm IV
Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.
placebo : Given orally
prochlorperazine : Given orally or IV
palonosetron hydrochloride : Given orally or IV
dexamethasone : Given orally or IV
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal
|
0.00%
0/254
|
0.00%
0/260
|
0.00%
0/254
|
0.40%
1/253 • Number of events 1
|
|
General disorders
Chest Pain
|
0.00%
0/254
|
0.38%
1/260 • Number of events 1
|
0.00%
0/254
|
0.00%
0/253
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
0.39%
1/254 • Number of events 1
|
0.00%
0/260
|
0.00%
0/254
|
0.00%
0/253
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place