Odansetron and Dexamethasone Alone vs. Odansetron, Dexamethason and Apreptant to Prevent Nausea
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.
|Nausea Vomiting||Drug: Standard PO ondansetron + dexamethasone Drug: aprepitant (MK-869) + PO ondansetron + dexamethasone||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Prospective, Randomized Phase III Trial of Oral Ondansetron and Dexamethasone Versus Oral Ondansetron, Dexamethasone and Apreptant (MK-869)for the Prevention of N/V Associated With Highly Emetogenic Preparative Regimens Prior to Stem Cell Transplantation.|
- To compare rate of complete response and toxicity during and 3 days after high dose therapy in pts treated with NK-1 antagonist, aprepitant, plus ondansetron and dexamethasone compared to ondansetron and dexam [ Time Frame: 14 days ]
|Study Start Date:||August 2003|
|Study Completion Date:||July 2010|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
|Placebo Comparator: 1||
Drug: Standard PO ondansetron + dexamethasone
Dexamethasone 10 mg (dose blinded) in 50 ml D5W IVPB over 15 minutes daily + ondansetron 8mg PO q 8 hours - repeated qd of the preparative regimen and for 1 day after completion. A placebo capsule will be given daily on each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.
|Active Comparator: 2||
Drug: aprepitant (MK-869) + PO ondansetron + dexamethasone
Dexamethasone 7.5 mg (dose blinded) in 50 ml D5W IVPB over 15 min daily + ondansetron 8mg PO q 8 hours - repeated QD of the preparative regimen and for 1 day after completion. Aprepitant 125mg PO [blinded] will be given a minimum of 30 minutes prior to the preparative regimen on day 1. MK-Aprepitant 80mg PO [blinded] will be given will be given approximately 24 hours later starting on day 2 then each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.
This will be a single center, comparative, randomized, double-blind, phase III trial designed to evaluate the efficacy of the NK-1 antagonist, aprepitant (MK-869), in combination with ondansetron and dexamethasone in the prevention of acute and delayed nausea and vomiting compared to ondansetron and dexamethasone in patients receiving highly emetogenic preparative regimens prior to autologous or allogeneic (related and unrelated) stem cell transplantation.
Patients will be randomized to one of two treatments: dexamethasone 10 mg IV once daily and ondansetron 8 mg orally every 8 hours on each day of the preparative regimen plus one additional day vs. 7.5 mg IV once daily and ondansetron 8 mg orally every 8 hours on each day of the preparative regimen plus one additional day combined with aprepitant, 125 mg orally on the first day of their preparative regimen followed by 80 mg daily on each remaining day of the preparative regimen plus three additional days.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00781768
|Principal Investigator:||Patrick Stiff, MD||Loyola University Cardinal Bernadin Cancer Center|