Odansetron and Dexamethasone Alone vs. Odansetron, Dexamethason and Apreptant to Prevent Nausea

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare two different treatment protocols for treating nausea and vomiting in patients who have undergone bone marrow transplant. Patients will be assigned to one of two treatment groups.

The first group will recieve ondansetron (Zofran) tablets combined with a medicine called dexamethasone given IV. Both of these drugs are commercially available.

Patients in the second treatment consists of the first two drugs, plus a newly approved drug known as aprepitant (MK-869, Emend). This combination will be the treatment being tested. The combination is approved by the FDA for chemotherapy regimens known to cause a lot of nausea and vomiting. It significantly decreases the delayed (more than 24 hours after therapy) nausea and vomiting seen with these regimens.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Loyola University
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Aprepitant; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Fosaprepitant; Ondansetron

Criteria

Inclusion Criteria:

• Diagnosis of cancer, admitted for myelosupppresive stem cell transplantation. Included preparative regimens include: TBI/VP16/CY, TBI/CY, BU/CY (PO & IV), and BCV

• Age 18 or older

• Alcohol intake <100 gm/d for the last year (< approximately 5 drinks per day)

• Renal function: estimated or measured CrCl 50 ml/min

• Liver function: T.Bili <1.5, AST < 2x ULN, unless due to disease

• Able to swallow tablets and capsules

Exclusion Criteria:

• Age < 18

• High alcohol intake [> 100 gm/d in the last year]

• Allergy or intolerance to: ondansetron or dexamethasone

• Renal dysfunction [measured or estimated CrCl < 50 ml/min]

• Liver dysfunction [T.Bili > 1.5, AST > 2x ULN, unless due to disease]

• Inability to swallow tablets or capsules

• Concurrent condition requiring systemic steroid use

• Nonmyeloablative SCT, patients receiving the conditioning regimens not included [see inclusion criteria]

• History of anticipatory nausea and vomiting