GA NCORP

NCORP Trials

A Unique Schedule of Palonosetron, Ondansetron, and Dexamethasone for the Prevention of Delayed Nausea and Vomiting in Patients Receiving Moderately Emetogenic Myeloablative Chemotherapy

Status
Completed
Cancer Type
Symptom Management
Trial Phase
Phase II
Eligibility
18 Years to 85 Years, Male and Female
Study Type
Prevention
NCD ID
NCT01370408
Protocol IDs
NSH 940 (primary)
Study Sponsor
Northside Hospital, Inc.

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.

Treatment Sites


Northside Hospital Cancer Institute
1000 Johnson Ferry Road NE
Atlanta, GA 30342
Northside Hospital Central Research Department
404-303-3355
www.northside.com