Emend for Multiple-day Emetogenic Chemotherapy

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Illinois at Chicago
• Collaborators: Merck Sharp & Dohme Corp.; Northwestern Memorial Hospital
• Treatments: Aprepitant; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Emetics; Fosaprepitant; Ondansetron

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.