Malignant NeoplasmNCT01640340
Ondansetron Versus Palonosetron Antiemetic Regimen Prior to Highly Emetogenic Chemotherapy(HEC)
A study testing aprepitant, palonosetron hydrochloride and ondansetron in people with Malignant Neoplasm, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
Palonosetron is different from ondansetron because it stays in the body longer and may prevent nausea and vomiting for a longer period of time than ondansetron. It is standard practice to use dexamethasone and aprepitant with either ondansetron or palonosetron to prevent nausea and vomiting caused by highly emetogenic… Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- aprepitant, palonosetron hydrochloride and ondansetron
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Aug 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed malignancy
- Chemotherapy naive or treated with only low or minimally emetogenic chemotherapy in the past (as defined by the National Comprehensive Cancer Network version [v].2.201 Antiemetic Guidelines)
- Scheduled to receive the first dose of their first cycle of HEC
- Patients receiving multi-day chemotherapy, the HEC portion must be on day 1 and the remaining days of chemotherapy must be minimally emetogenic (i.e. fluorouracil)
- Performance status of Eastern Cooperative Oncology Group (ECOG) grade 0-2
- Able to provide informed consent
Show all 13Show fewer
- Able to read and write in English or have someone that can that can translate to them and record their diary entries
- Able to take oral medications
- Patients are allowed to participate in a concurrent clinical trial, if the other trial:
- Does not mandate an antiemetic regimen that interferes with this study
- Allows antiemetic administration at the physician's discretion
- Does not prohibit the patient from participating in this study
- Patients must be willing to participate with daily diary entries for 5 days following chemotherapy, and agree to have a 5 minute follow-up call on day 2 or 3 and day 5, 6 or 7
Who cannot join
- Has stage IV (metastatic) disease
- Known hypersensitivity to ondansetron, palonosetron, aprepitant, or dexamethasone
- Have received or will receive agents that are strong cytochrome P450 3A4 (CYP450 3A4) inducers and/or inhibitors and known to cause clinically relevant drug interactions within one week prior to study treatment and continuing through day 5; any vomiting or retching within 24 hours before administration of chemotherapy
- Grade 2 nausea or greater, according to the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v 4.0) within 24 hours before administration of chemotherapy
- Received an antiemetic within 24 hours before study drug administration, excluding the use of benzodiazepines
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2.5 times upper limit of normal
- Total bilirubin > 1.5 times upper limit of normal
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: Pilot Study on the Efficacy of an Ondansetron Versus Palonosetron-containing Antiemetic Regimen Prior to Highly Emetogenic Chemotherapy(HEC).
Palonosetron is different from ondansetron because it stays in the body longer and may prevent nausea and vomiting for a longer period of time than ondansetron. It is standard practice to use dexamethasone and aprepitant with either ondansetron or palonosetron to prevent nausea and vomiting caused by highly emetogenic chemotherapy. Although these combinations are commonly used, they have never been compared to each other. The purpose of this study is to record the amount of nausea and vomiting, and the amount of "rescue" medication that is used with these two different anti-emetic regimens
Read the detailed description
PRIMARY OBJECTIVES:
- The goal of this study is to evaluate the overall complete response rate (CR, no emesis and no use of rescue medication from 0 to 120 hours after chemotherapy) of two different antiemetic regimens (palonosetron + aprepitant + dexamethasone and ondansetron + aprepitant + dexamethasone) for patients undergoing the first cycle of highly emetogenic chemotherapy (HEC).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive palonosetron hydrochloride intravenously (IV) 30 minutes prior to chemotherapy on day 1, aprepitant orally (PO) 60 minutes prior to chemotherapy on days 1-3, and dexamethasone PO 30 minutes prior to chemotherapy on days 1-4.
ARM II: Patients receive ondansetron PO 30 minutes prior to chemotherapy on day 1 and aprepitant and dexamethasone as in Arm I.
After completion of study treatment, patients are followed up for 7 days.
- Conditions
- Malignant Neoplasm
- Being tested
- aprepitant, palonosetron hydrochloride, ondansetron, dexamethasone
- Keywords
- ondansetron, palonosetron, emetogenic chemotherapy, HEC
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aprepitantDrug
Also called Emend, L-754030, MK-0869, ONO-7436
Given by mouth
palonosetron hydrochlorideDrug
Also called Aloxi, RS 25259-197
Given IV(intervenous infusion)
ondansetronDrug
Also called GR 38032F, GR-C507/75, Zofran
Given PO
dexamethasoneDrug
Also called Aeroseb-Dex, Decaderm, Decadron, DM
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm I (palonosetron hydrochloride) | Experimental | Patients receive palonosetron hydrochloride IV 30 minutes prior to chemotherapy on day 1, aprepitant PO (by mouth) 60 minutes prior to chemotherapy on days 1-3, and dexamethasone PO 30 minutes prior to chemotherapy on days 1-4. Receives: Drug: aprepitant; Drug: palonosetron hydrochloride; Drug: dexamethasone |
| Arm II (ondansetron) | Experimental | Patients receive ondansetron PO 30 minutes prior to chemotherapy on day 1 and aprepitant and dexamethasone as in Arm I. Receives: Drug: aprepitant; Drug: ondansetron; Drug: dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall CR(Complete Response)After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication
We will use exact binomial methods to estimate proportions and their associated 95% confidence intervals.
Measured: Up to 120 hours after completion of chemotherapy
Secondary outcomes (6)
Acute CR (Complete Response)
After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication from time 0 to 24 hours.
Measured: 0-24 hours after chemotherapy
Delayed CR (Complete Response)
After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication From Time 24to 120 Hours.
Measured: 24-120 hours after chemotherapy
Percentage of Patients Who Experienced Grade 1, 2 or 3 Nausea From 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.
Measured: Time 0 to 120 hours
Visual Analog Scale (VAS) Scores
Measured: Up to 7 days after completion of study treatment
Use of Rescue Medication for Each Treatment Arm
Measured: From time 0 to 120 hours
Percentage of Patients Who Experienced Grade 1, 2 or 3 Vomiting 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.
Measured: From time 0 to 120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study startJan 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Layman, Ohio State University Comprehensive Cancer Center
- Investigators
- Rachel Layman, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640340
- Sponsor's protocol ID
- OSU-10118
- Other IDs
- NCI-2012-01009
- Status last verified
- Oct 2013
- First submitted
- 10 Jul 2012
- Last updated
- 7 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Efficacy of an Ondansetron Versus Palonosetron-containing Antiemetic Regimen Prior to Highly Emetogenic Chemotherapy(HEC).
- ClinicalTrials.gov ID
- NCT01640340
- Acronym / sponsor ID
- OSU-10118
- Conditions
- Malignant Neoplasm
- Keywords
- ondansetron, palonosetron, emetogenic chemotherapy, HEC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 13 Jul 2012 (estimated)
- Results
- Posted 7 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Palonosetron is different from ondansetron because it stays in the body longer and may prevent nausea and vomiting for a longer period of time than ondansetron. It is standard practice to use dexamethasone and aprepitant with either ondansetron or palonosetron to prevent nausea and vomiting caused by highly emetogenic chemotherapy. Although these combinations are commonly used, they have never been compared to each other. The purpose of this study is to record the amount of nausea and vomiting, and the amount of "rescue" medication that is used with these two different anti-emetic regimens
Detailed description
PRIMARY OBJECTIVES:
- The goal of this study is to evaluate the overall complete response rate (CR, no emesis and no use of rescue medication from 0 to 120 hours after chemotherapy) of two different antiemetic regimens (palonosetron + aprepitant + dexamethasone and ondansetron + aprepitant + dexamethasone) for patients undergoing the first cycle of highly emetogenic chemotherapy (HEC).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive palonosetron hydrochloride intravenously (IV) 30 minutes prior to chemotherapy on day 1, aprepitant orally (PO) 60 minutes prior to chemotherapy on days 1-3, and dexamethasone PO 30 minutes prior to chemotherapy on days 1-4.
ARM II: Patients receive ondansetron PO 30 minutes prior to chemotherapy on day 1 and aprepitant and dexamethasone as in Arm I.
After completion of study treatment, patients are followed up for 7 days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (palonosetron hydrochloride) | Experimental | Drug: aprepitant, Drug: palonosetron hydrochloride, Drug: dexamethasonePatients receive palonosetron hydrochloride IV 30 minutes prior to chemotherapy on day 1, aprepitant PO (by mouth) 60 minutes prior to chemotherapy on days 1-3, and dexamethasone PO 30 minutes prior to chemotherapy on days 1-4. |
| Arm II (ondansetron) | Experimental | Drug: aprepitant, Drug: ondansetron, Drug: dexamethasonePatients receive ondansetron PO 30 minutes prior to chemotherapy on day 1 and aprepitant and dexamethasone as in Arm I. |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Confirmed malignancy
- Chemotherapy naive or treated with only low or minimally emetogenic chemotherapy in the past (as defined by the National Comprehensive Cancer Network version [v].2.201 Antiemetic Guidelines)
- Scheduled to receive the first dose of their first cycle of HEC
- Patients receiving multi-day chemotherapy, the HEC portion must be on day 1 and the remaining days of chemotherapy must be minimally emetogenic (i.e. fluorouracil)
- Performance status of Eastern Cooperative Oncology Group (ECOG) grade 0-2
Key exclusion criteria (7 listed)
- Has stage IV (metastatic) disease
- Known hypersensitivity to ondansetron, palonosetron, aprepitant, or dexamethasone
- Have received or will receive agents that are strong cytochrome P450 3A4 (CYP450 3A4) inducers and/or inhibitors and known to cause clinically relevant drug interactions within one week prior to study treatment and continuing through day 5; any vomiting or retching within 24 hours before administration of chemotherapy
- Grade 2 nausea or greater, according to the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v 4.0) within 24 hours before administration of chemotherapy
- Received an antiemetic within 24 hours before study drug administration, excluding the use of benzodiazepines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aprepitantAlso: Emend, L-754030, MK-0869, ONO-7436Given by mouth | Drug | Arm I (palonosetron hydrochloride), Arm II (ondansetron) |
| palonosetron hydrochlorideAlso: Aloxi, RS 25259-197Given IV(intervenous infusion) | Drug | Arm I (palonosetron hydrochloride) |
| ondansetronAlso: GR 38032F, GR-C507/75, ZofranGiven PO | Drug | Arm II (ondansetron) |
| dexamethasoneAlso: Aeroseb-Dex, Decaderm, Decadron, DMGiven PO | Drug | Arm I (palonosetron hydrochloride), Arm II (ondansetron) |
Primary outcome
Overall CR(Complete Response)After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication
Time frame: Up to 120 hours after completion of chemotherapy
We will use exact binomial methods to estimate proportions and their associated 95% confidence intervals.
6 secondary outcomes
Acute CR (Complete Response)
Time frame: 0-24 hours after chemotherapy
Delayed CR (Complete Response)
Time frame: 24-120 hours after chemotherapy
Percentage of Patients Who Experienced Grade 1, 2 or 3 Nausea From Time 0 to 120 Hours
Time frame: Time 0 to 120 hours
Visual Analog Scale (VAS) Scores
Time frame: Up to 7 days after completion of study treatment
Use of Rescue Medication for Each Treatment Arm
Time frame: From time 0 to 120 hours
Percentage of Patients Who Experienced Grade 1, 2 or 3 Vomiting From Time 0 to 120 Hours
Time frame: From time 0 to 120 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- JameslineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Layman principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aprepitant, palonosetron hydrochloride and ondansetron in people with Malignant Neoplasm, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall CR(Complete Response)After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication (time frame: Up to 120 hours after completion of chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2013.