Phase 2
N=85
Palonosetron, Ondansetron, and Dexamethasone for Delayed Nausea and Vomiting in Autologous Transplant Patients
Chemotherapy-induced Nausea and Vomiting
Bottom Line
View on ClinicalTrials.gov: NCT01370408 ↗Enrolled (actual)
85
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Complete Response Rate for Delayed Chemotherapy Induced Nausea & Vomiting — 13 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Palonosetron (Drug); ondansetron (Drug); Dexamethasone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northside Hospital, Inc.
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Response Rate for Delayed Chemotherapy Induced Nausea & Vomiting |
13 | — |
| SECONDARY Complete Remission During Acute Phase Post-chemotherapy |
33 | — |
| SECONDARY Complete Remission During Overall Chemotherapy Time Period |
10 | — |
| SECONDARY Complete Control Rate for Nausea & Vomiting |
8 | — |
| SECONDARY Emetic Episodes |
1.7 | — |
| SECONDARY Patients Who Experience First Emetic Episode Within 24 Hours |
15 | — |
| SECONDARY Number of Patients That Required First Administration of Rescue Medication Within 24 Hours |
46 | — |
| SECONDARY Number of Patients That Experience Treatment Failure Within the First 24 Hours |
49 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- 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
- Melphalan
- Negative pregnancy test
- Must be able to complete a daily nausea/vomiting questionnaire and Quality of Life
Exclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT01370408). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.