Clinical trial NCT00781768: Odansetron and Dexamethasone Alone vs. Odansetron, Dexamethason and Apreptant to Prevent Nausea
Official title: Prevention of Nausea and Vomitting Associated With Stem Cell Transplant: Results of a Prospective, Randomized Trial of Aprepitant Used With Highly Emetogenic Preparative Regimens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nausea
Vomiting
Keywords: Bone Marrow Transplant
Nausea
Vomiting
NK-1 antagonist
Lead sponsor: Loyola University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-10-29
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Complete Response Rates Among Standard of Care and Combination Therapy Groups.
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Loyola University Cardinal Bernadin Cancer Center
name: Patrick Stiff, MD
role: PRINCIPAL_INVESTIGATOR
References: