Chemotherapy-induced Nausea and VomitingPhase 2NCT01370408
Palonosetron, Ondansetron, and Dexamethasone for Delayed Nausea and Vomiting in Autologous Transplant Patients
A Phase 2 study testing Palonosetron, ondansetron and Dexamethasone in people with Chemotherapy-induced Nausea and Vomiting, run by Northside Hospital, Inc. at 1 site in United States.
Trial summary
In this study, patients will receive ondansetron 8mg and dexamethasone 10mg intravenously 30 minutes prior to myeloablative preparative chemotherapy until the last day of chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chemotherapy-induced Nausea and Vomiting
- What is being tested?
- Palonosetron, ondansetron and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Mar 2016
- Phase
- Phase 2
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- candidate for high-dose chemotherapy and autologous hematopoietic stem cell transplantation
- Karnofsky performance status >/= 60%
- scheduled to receive one of the following conditioning regimens
- BEAM
- Oral Busulfan/cyclophosphamide with or without etoposide
- Carboplatin/Etoposide
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- Melphalan
- Negative pregnancy test
- Must be able to complete a daily nausea/vomiting questionnaire and Quality of Life
Who cannot join
- Active infection requiring IV antibiotics
- Known active hepatitis B and/or hepatitis C or HIV infection
- prior non-hematological malignancies at other sites except surgically treated non-melanoma skin cancer, superficial cervical cancer or other cancer from which the patient had been disease free for >/= 5 years
- Uncontrolled medical problems including any of the following
- Diabetes mellitus
- Cardiac, pulmonary, hepatic or renal disease
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- myocardial infarction within the past 6 months
- Morbid obesity (BMT >40)
- History of CNS metastases, psychiatric or CNS disorders interfering with the ability to comply with the study
- Known hypersensitivity to 5-HT3 antagonists, dexamethasone and/or their components
- Intrathecal therapy within 24 hours before starting preparative regimen
- Receiving any antiemetic therapy 24 hours before starting preparative regimen
- Any 5-HT3 antagonist used as a rescue medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Unique Schedule of Palonosetron, Ondansetron, and Dexamethasone for the Prevention of Delayed Nausea and Vomiting in Patients Receiving Moderately Emetogenic Myeloablative Chemotherapy
In this study, patients will receive ondansetron 8mg and dexamethasone 10mg intravenously 30 minutes prior to myeloablative preparative chemotherapy until the last day of chemotherapy. On the final day of chemotherapy, palonosetron 0.25mg and dexamethasone 10mg will be administered intravenously 30 minutes prior to the chemotherapy. If the chemotherapy regimen is only 1 day of the chemotherapy then only palonosetron and dexamethasone will be administered 30 minutes prior to chemotherapy. Dexamethasone 8mg once daily will be given orally for 2 days following chemotherapy.
Read the detailed description
In order to decrease this delayed CINV, the investigators have developed a unique schedule of antiemetics that takes advantage of palonosetron's long elimination half-life (40 hours). In this study, patients will receive ondansetron 8mg and dexamethasone 10mg intravenously 30 minutes prior to myeloablative preparative chemotherapy until the last day of chemotherapy. On the final day of chemotherapy, palonosetron 0.25mg and dexamethasone 10mg will be administered intravenously 30 minutes prior to the chemotherapy. If the chemotherapy regimen is only 1 day of the chemotherapy then only palonosetron and dexamethasone will be administered 30 minutes prior to chemotherapy. Dexamethasone 8mg once daily will be given orally for 2 days following chemotherapy. The investigators hypothesize that this antiemetic schedule will significantly reduce the delayed CINV compared to historical controls
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Being tested
- Palonosetron, ondansetron, Dexamethasone
- Keywords
- Autologous stem cell transplant, BEAM, Oral busulfan, Cyclophosphamide, Etoposide, Carboplatin, melphalan
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalonosetronDrug
Also called Aloxi
Prior to IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV On the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
ondansetronDrug
Also called zofran
Prior to IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV On the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV
DexamethasoneDrug
Also called Dex
Prior to IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV On the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV
| Study group | Role | What they receive |
|---|---|---|
| Palonosetron | Experimental | All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation
Prior to IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV on the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO Receives: Drug: Palonosetron; Drug: ondansetron; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate for Delayed Chemotherapy Induced Nausea & Vomiting
Proportion of patients achieving a delayed CINV complete response (CR) defined as no emetic episode and no use of rescue medications during the 24-120 hour period post chemotherapy.
Measured: 120 hours
Secondary outcomes (7)
Complete Remission During Acute Phase Post-chemotherapy
Proportion of patients achieving an acute CINV CR during the acute phase post -chemotherapy (0-24 hours)
Measured: 24 hours
Complete Remission During Overall Chemotherapy Time Period
Proportion of patients achieving a CR during the cumulative overall 0-120 hour time period
Measured: 120 hours
Complete Control Rate for Nausea & Vomiting
Complete control rate (CC; defined as no emetic episodes, no rescue medication use, and no more than mild nausea)
Measured: 120 hours
Emetic Episodes
Number of emetic episodes
Measured: 120 Hours
Patients Who Experience First Emetic Episode Within 24 Hours
Number of patients with first emetic episode experienced within 24 hours
Measured: 24 hours
Number of Patients That Required First Administration of Rescue Medication Within 24 Hours
Number of patients who required the use of rescue medication (lorazepam, prochlorperazine, promethazine, metoclopramide, scopolamine, or dronabinol) within the first 24 hours
Measured: 24 hours
Number of Patients That Experience Treatment Failure Within the First 24 Hours
Number of patients with first emetic episode or time to administration of rescue therapy, whichever occurred first, within the first 24 hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study startFeb 2012
- Primary completionMar 2016
- Study completionMar 2016
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 Chemotherapy-induced Nausea and VomitingStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northside Hospital, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Blood and Marrow Transplant Group of Georgia
- Responsible party
- Sponsor
- Investigators
- Scott R Solomon, MD, Principal investigator, Blood and Marrow Transplant Group of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370408
- Sponsor's protocol ID
- NSH 940
- Status last verified
- Mar 2017
- First submitted
- 8 Jun 2011
- Last updated
- 17 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Unique Schedule of Palonosetron, Ondansetron, and Dexamethasone for the Prevention of Delayed Nausea and Vomiting in Patients Receiving Moderately Emetogenic Myeloablative Chemotherapy
- ClinicalTrials.gov ID
- NCT01370408
- Acronym / sponsor ID
- NSH 940
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Keywords
- Autologous stem cell transplant, BEAM, Oral busulfan, Cyclophosphamide, Etoposide, Carboplatin, melphalan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Northside Hospital, Inc.University, hospital or other
- Collaborators
- Blood and Marrow Transplant Group of Georgia
- Study start
- Feb 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 9 Jun 2011 (estimated)
- Results
- Posted 6 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, patients will receive ondansetron 8mg and dexamethasone 10mg intravenously 30 minutes prior to myeloablative preparative chemotherapy until the last day of chemotherapy. On the final day of chemotherapy, palonosetron 0.25mg and dexamethasone 10mg will be administered intravenously 30 minutes prior to the chemotherapy. If the chemotherapy regimen is only 1 day of the chemotherapy then only palonosetron and dexamethasone will be administered 30 minutes prior to chemotherapy. Dexamethasone 8mg once daily will be given orally for 2 days following chemotherapy.
Detailed description
In order to decrease this delayed CINV, the investigators have developed a unique schedule of antiemetics that takes advantage of palonosetron's long elimination half-life (40 hours). In this study, patients will receive ondansetron 8mg and dexamethasone 10mg intravenously 30 minutes prior to myeloablative preparative chemotherapy until the last day of chemotherapy. On the final day of chemotherapy, palonosetron 0.25mg and dexamethasone 10mg will be administered intravenously 30 minutes prior to the chemotherapy. If the chemotherapy regimen is only 1 day of the chemotherapy then only palonosetron and dexamethasone will be administered 30 minutes prior to chemotherapy. Dexamethasone 8mg once daily will be given orally for 2 days following chemotherapy. The investigators hypothesize that this antiemetic schedule will significantly reduce the delayed CINV compared to historical controls
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Palonosetron | Experimental | Drug: Palonosetron, Drug: ondansetron, Drug: DexamethasoneAll patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation Prior to IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV on the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- candidate for high-dose chemotherapy and autologous hematopoietic stem cell transplantation
- Karnofsky performance status >/= 60%
- scheduled to receive one of the following conditioning regimens
- BEAM
- Oral Busulfan/cyclophosphamide with or without etoposide
Key exclusion criteria (13 listed)
- Active infection requiring IV antibiotics
- Known active hepatitis B and/or hepatitis C or HIV infection
- prior non-hematological malignancies at other sites except surgically treated non-melanoma skin cancer, superficial cervical cancer or other cancer from which the patient had been disease free for >/= 5 years
- Uncontrolled medical problems including any of the following
- Diabetes mellitus
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 |
|---|---|---|
| PalonosetronAlso: AloxiPrior to IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV On the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO | Drug | Palonosetron |
| ondansetronAlso: zofranPrior to IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV On the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV | Drug | Palonosetron |
| DexamethasoneAlso: DexPrior to IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV On the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV | Drug | Palonosetron |
Primary outcome
Complete Response Rate for Delayed Chemotherapy Induced Nausea & Vomiting
Time frame: 120 hours
Proportion of patients achieving a delayed CINV complete response (CR) defined as no emetic episode and no use of rescue medications during the 24-120 hour period post chemotherapy.
7 secondary outcomes
Complete Remission During Acute Phase Post-chemotherapy
Time frame: 24 hours
Complete Remission During Overall Chemotherapy Time Period
Time frame: 120 hours
Complete Control Rate for Nausea & Vomiting
Time frame: 120 hours
Emetic Episodes
Time frame: 120 Hours
Patients Who Experience First Emetic Episode Within 24 Hours
Time frame: 24 hours
Number of Patients That Required First Administration of Rescue Medication Within 24 Hours
Time frame: 24 hours
Number of Patients That Experience Treatment Failure Within the First 24 Hours
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Scott R Solomon, MD principal investigator
Blood and Marrow Transplant Group of Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Palonosetron, ondansetron and Dexamethasone in people with Chemotherapy-induced Nausea and Vomiting, run by Northside Hospital, Inc. 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 9 inclusion and 13 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 17 Apr 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2017). 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?
Complete Response Rate for Delayed Chemotherapy Induced Nausea & Vomiting (time frame: 120 hours). 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 17 Apr 2017; AzTrials last refreshed its copy on 7 Nov 2026.