Status:
COMPLETED
Emend for Multiple-day Emetogenic Chemotherapy
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Northwestern Memorial Hospital
Conditions:
Nausea
Vomiting
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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' ...
Detailed Description
In the studies leading to aprepitant's approval, subjects received only one dose of highly emetogenic chemotherapy. Campos et al studied subjects who received their first course of cisplatin containin...
Eligibility Criteria
Inclusion
- Subjects with a life expectancy \> 3 months
- Subjects with an ECOG performance score \< 3
- Subjects with access to a telephone for follow-up
- Subjects able to swallow tablets and capsules
Exclusion
- Subjects who previously received aprepitant as prophylaxis for chemotherapy induced nausea and vomiting.
- Subjects with an allergy, hypersensitivity, or contraindication to aprepitant, dexamethasone, prochlorperazine or a serotonin receptor antagonist.
- Subject with uncontrolled diabetes or a concurrent illness/condition requiring chronic systemic steroids or pre-existing gastrointestinal pathology.
- Subjects with a history of excessive alcohol consumption.
- Women who are pregnant or lactating.
- Subjects with nausea at baseline or chronically using other antiemetic agent(s).
- Subjects currently receiving another investigational agent.
- Subjects taking a medication that can interact with aprepitant, including the following medications:
- warfarin
- oral contraceptives
- tolbutamide
- phenytoin
- midazolam
- ketoconazole
- rifampin
- paroxetine
- diltiazem
- Subjects with poor hepatic or renal function defined as AST \> 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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00711555
Start Date
November 1 2005
End Date
January 1 2009
Last Update
August 4 2021
Active Locations (1)
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1
University of Illinois Medical Center
Chicago, Illinois, United States, 60612