Status:
COMPLETED
Aprepitant in Preventing Nausea and Vomiting in Patients Who Are Undergoing a Stem Cell Transplant
Lead Sponsor:
OHSU Knight Cancer Institute
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
RATIONALE: Antiemetic drugs, such as aprepitant, ondansetron, and dexamethasone, may help lessen or prevent nausea and vomiting in patients undergoing a stem cell transplant. PURPOSE: This randomized...
Detailed Description
OBJECTIVES: Primary * Compare the efficacy of standard antiemetic therapy comprising ondansetron and dexamethasone combined with either aprepitant or placebo in controlling nausea and vomiting, as d...
Eligibility Criteria
Inclusion
- Inclusion:
- 18 years of age or greater
- must be scheduled for an autologous or allogeneic bone marrow or peripheral stem cell transplant
- Eastern Cooperative Oncology Group(ECOG) performance status \< or = 2
- patients must have signed informed consent
- must be able to swallow tablets and capsules
- must be receiving a cyclophosphamide containing regimen.
- Exclusion:
- patient has known sensitivity to aprepitant, ondansetron, or dexamethasone
- patient has received another investigational drug in the past 30 days
- patient has had emesis or requires antiemetic agents in the 48 hours prior to beginning conditioning therapy
- patient has taken neurokinin-1 antagonists for 14 days prior to enrollment
- patient is pregnant, has a positive serum human chorionic gonadotropin(hCg) or is lactating
- patient has serum creatinine level \> or = 2\*ULN
- patient has severe hepatic insufficiency (Child-Pugh score \>9)
- patient drinks \> 5 drinks/day for the last year
- patient with concurrent illness requiring systemic corticosteroid use other than planned dexamethasone during conditioning therapy
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00248547
Start Date
May 1 2004
End Date
January 1 2009
Last Update
May 9 2017
Active Locations (1)
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1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239-3098