Palonosetron, Ondansetron, and Dexamethasone for Delayed Nausea and Vomiting in Autologous Transplant Patients
Information source: Northside Hospital, Inc.
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chemotherapy-induced Nausea and Vomiting
Intervention: Palonosetron, ondansetron, dexamethasone (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Northside Hospital, Inc. Official(s) and/or principal investigator(s):
Scott R Solomon, MD, Principal Investigator, Affiliation: Blood and Marrow Transplant Group of Georgia
Overall contact:
Stacey Brown, BA, Phone: 404-851-8238, Email: stacey.brown@Northside.com
Summary
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
Clinical Details
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
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Complete Response Rate for delayed chemotherapy induced nauseas & vomiting
Secondary outcome: COmplete remission during actue phase post-chemotherapyComplete remission during overall chemotherapy time period Complete control rate for nausea & vomiting Emetic episodes First emetic episode First administration of rescue medication Treatment failure Severity of nausea Quality of life (QOL)
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
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
Locations and Contacts
Stacey Brown, BA, Phone: 404-851-8238, Email: stacey.brown@Northside.com
Northside Hospital, Atlanta, Georgia 30342, United States; Recruiting
Stacey Brown, BA, Phone: 404-851-8238, Email: stacey.brown@northside.com
Justin Laporte, PharmD, Phone: 404-255-1930, Email: justin.laporte@northside.com
H. Kent Holland, MD, Sub-Investigator
Asad Bashey, MD, Sub-Investigator
Lawrence E Morris, MD, Sub-Investigator
Justin Laporte, PharmD, Sub-Investigator
Additional Information
Starting date: February 2012
Last updated: October 8, 2012
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