Trial Outcomes & Findings for Ondansetron Versus Palonosetron Antiemetic Regimen Prior to Highly Emetogenic Chemotherapy(HEC) (NCT NCT01640340)

Results Overview

We will use exact binomial methods to estimate proportions and their associated 95% confidence intervals.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

Up to 120 hours after completion of chemotherapy

Results posted on

2013-11-07

Participant Flow

Patients were screened for eligibility during routine clinic visits by a physician, nurse practitioner or pharmacist involved in their care.

Patients were stratified based upon their chemotherapy regimen (cisplatin versus noncisplatin containing) and then randomized to the ondansetron or palonosetron group.

Participant milestones

Participant milestones
Measure	Arm A (Palonosetron 0.25 mg IV on Day 1) Palonosetron 0.25 mg day 1; aprepitant 125 mg day 1, 80 mg days 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4	Arm B (Ondansetron 24 mg Oral on Day 1) Ondansetron 24 mg day 1; aprepitant 125 mg day 1, 80 mg day 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4
Overall Study STARTED	20	20
Overall Study Overall Complete Response Rate	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ondansetron Versus Palonosetron Antiemetic Regimen Prior to Highly Emetogenic Chemotherapy(HEC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A n=20 Participants Palonosetron 0.25 mg day 1; aprepitant 125 mg day 1, 80 mg day 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4	Arm B n=20 Participants Ondansetron 24 mg day 1; aprepitant 125 mg day 1, 80 mg day 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 120 hours after completion of chemotherapy

We will use exact binomial methods to estimate proportions and their associated 95% confidence intervals.

Outcome measures

Outcome measures
Measure	Arm A (Palonosetron 0.25 mg IV on Day 1) n=20 Participants Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.	Arm B (Ondansetron 24 mg Oral on Day 1) n=20 Participants Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
Overall CR(Complete Response)After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication	65 percentage of patients Interval 40.8 to 84.6	40 percentage of patients Interval 19.1 to 63.9

SECONDARY outcome

Timeframe: 0-24 hours after chemotherapy

After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication from time 0 to 24 hours.

Outcome measures

Outcome measures
Measure	Arm A (Palonosetron 0.25 mg IV on Day 1) n=20 Participants Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.	Arm B (Ondansetron 24 mg Oral on Day 1) n=20 Participants Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
Acute CR (Complete Response)	75 percentage of particpants	55 percentage of particpants

SECONDARY outcome

Timeframe: 24-120 hours after chemotherapy

After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication From Time 24to 120 Hours.

Outcome measures

Outcome measures
Measure	Arm A (Palonosetron 0.25 mg IV on Day 1) n=20 Participants Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.	Arm B (Ondansetron 24 mg Oral on Day 1) n=20 Participants Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
Delayed CR (Complete Response)	65 percentage of participants	45 percentage of participants

SECONDARY outcome

Timeframe: Time 0 to 120 hours

The percentage of patients who experienced grade 1, 2 or 3 nausea from time 0 to 120 hours. Nausea graded using the National Cancer Institute (NCI) CTCAE (Common Toxicity Criteria for Adverse Effects)version 4.0 Nausea Grading Scale. Grade 1=Loss of appetite without alteration in eating habits, Grade 2= Oral intake decreased without significant weight loss, dehydration or malnutrition, Grade 3= Inadequate oral caloric or fluid intake; tube feeding, TPN, or hospitalization indicated.

Outcome measures

Outcome measures
Measure	Arm A (Palonosetron 0.25 mg IV on Day 1) n=20 Participants Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.	Arm B (Ondansetron 24 mg Oral on Day 1) n=20 Participants Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
Percentage of Patients Who Experienced Grade 1, 2 or 3 Nausea From Time 0 to 120 Hours	55 percentage of participants	65 percentage of participants

SECONDARY outcome

Timeframe: Up to 7 days after completion of study treatment

Population: VAS Scores were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From time 0 to 120 hours

Outcome measures

Outcome measures
Measure	Arm A (Palonosetron 0.25 mg IV on Day 1) n=20 Participants Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.	Arm B (Ondansetron 24 mg Oral on Day 1) n=20 Participants Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
Use of Rescue Medication for Each Treatment Arm	35 percentage of participants	55 percentage of participants

SECONDARY outcome

Timeframe: From time 0 to 120 hours

The percentage of patients who experienced grade 1, 2 or 3 vomiting from time 0 to 120 hours. Nausea graded using the National Cancer Institute (NCI) CTCAE v 4.0 vomiting Grading Scale. Grade 1=Loss of appetite without alteration in eating habits, Grade 2= Oral intake decreased without significant weight loss, dehydration or malnutrition, Grade 3= Inadequate oral caloric or fluid intake; tube feeding, TPN, or hospitalization indicated.

Outcome measures

Outcome measures
Measure	Arm A (Palonosetron 0.25 mg IV on Day 1) n=20 Participants Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.	Arm B (Ondansetron 24 mg Oral on Day 1) n=20 Participants Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
Percentage of Patients Who Experienced Grade 1, 2 or 3 Vomiting From Time 0 to 120 Hours	5 percentage of participants	15 percentage of participants

Adverse Events

Arm A

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A n=20 participants at risk Palonosetron 0.25 mg day 1; aprepitant 125 mg day 1, 80 mg day 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4	Arm B n=20 participants at risk Ondansetron 24 mg day 1; aprepitant 125 mg day 1, 80 mg day 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4
Gastrointestinal disorders Pancreatitis	5.0% 1/20 • Number of events 1 • Days 1 through 5 following chemotherapy Patients were given a diary on the day of treatment to record symptoms experienced on days 1 through 6. Although symptoms were documented on days 1 through 6, they were only evaluated based upon days 1 through 5. The additional day of recording was instituted to ensure the investigators captured the entire day 1 through time period.	0.00% 0/20 • Days 1 through 5 following chemotherapy Patients were given a diary on the day of treatment to record symptoms experienced on days 1 through 6. Although symptoms were documented on days 1 through 6, they were only evaluated based upon days 1 through 5. The additional day of recording was instituted to ensure the investigators captured the entire day 1 through time period.

Other adverse events

Adverse event data not reported

Additional Information

Rachel Layman, MD

Ohio State University Medical Center

Phone: 614-293-0066

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place