Phase 2
N=22
Emend for Multiple-day Emetogenic Chemotherapy
Nausea · Vomiting
Bottom Line
View on ClinicalTrials.gov: NCT00711555 ↗Enrolled (actual)
22
Serious AEs
—
Results posted
Aug 2009
Primary outcome: Primary: Complete Response (Percentage of Patients) — 84 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- aprepitant, ondansetron, dexamethasone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Illinois at Chicago
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Response (Percentage of Patients) |
84 | — |
| SECONDARY Complete Protection |
74 | — |
| SECONDARY no Emesis |
100 | — |
| SECONDARY no Nausea |
74 | — |
| SECONDARY no Significant Nausea |
79 | — |
Summary
The purpose of the study is to assess the effect of Emend (aprepitant) on nausea and vomiting associated with chemotherapy. Chemotherapy commonly causes nausea and vomiting and this affects patients' quality of life and attitudes toward treatment. Although nausea and vomiting associated with chemotherapy has been decreasing due to improved therapy, some patients will still experience this side effect. Therefore, new medications are needed to decrease the amount of nausea and vomiting patients have with chemotherapy. Emend (aprepitant) is a new medication used to treat nausea and vomiting with chemotherapy, but it has only been studied in patients receiving only one dose of chemotherapy that makes most people sick. However, there is little experience with this medication in patients receiving multiple days of chemotherapy that causes nausea and vomiting.
Eligibility Criteria
Inclusion Criteria
- Subjects with a life expectancy > 3 months
- Subjects with an ECOG performance score 3 x ULN, ALT > 3 x ULN, total bilirubin > 3 x ULN, alkaline phosphatase > 3 x ULN or serum creatinine >2 mg/dl measured within three months before starting chemotherapy.
Subjects with hepatic metastases with AST > 5 x ULN, ALT > 5 x ULN, total bilirubin > 5 x ULN, alkaline phosphatase > 5 x ULN.
Data sourced from ClinicalTrials.gov (NCT00711555). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.