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.
18 Years
N/A
Both
Nausea, Vomiting
Trial Information
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.
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
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
Outcome Time Frame:
14 days
Safety Issue:
Yes
Principal Investigator
Patrick Stiff, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Loyola University Cardinal Bernadin Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
106578
NCT ID:
NCT00781768
Start Date:
August 2003
Completion Date:
July 2010
Related Keywords:
- Nausea
- Vomiting
- Bone Marrow Transplant
- Nausea
- Vomiting
- NK-1 antagonist
- Nausea and vommitting in the stem cell/marrow transplant population.
- Nausea
- Vomiting
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