Emend for Multiple-day Emetogenic Chemotherapy
Condition: Nausea; Vomiting
MeSH terms: Nausea; Vomiting
Intervention: aprepitant, ondansetron, dexamethasone
Intervention description: On day 1, the subject will receive a total daily dose of oral dexamethasone 12mg, oral ondansetron 24mg, and oral aprepitant 125mg. On days 2 to THE LAST DAY OF THE MODERATELY-HIGH TO HIGHLY EMETOGENIC CHEMOTHERAPY, subjects will receive a total daily dose of oral dexamethasone 12mg, oral ondansetron 24mg, and oral aprepitant 80mg. All anti-emetics should be give one hour before starting chemotherapy administration.
FOR TWO DAYS AFTER RECEIVING CHEMOTHERAPY, the subject will be prescribed oral dexamethasone 4mg every 12 hours and oral aprepitant 80 mg every day.
FOR RESCUE, the subject will be prescribed prochlorperazine 10 mg oral every 4 hours as needed for nausea and prochlorperazine 10 mg intravenous every 4 hours as needed for vomiting.
Intervention MeSH terms: Dexamethasone; Ondansetron; Aprepitant
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: nausea; vomiting; multiple days; chemotherapy; serotonin receptor antagonist; corticosteroids; aprepitant; rescue therapy

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

          -  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.