Fosaprepitant (MK-0517, EMEND® IV) In Salvage Treatment of Chemotherapy-Induced Vomiting (MK-0517-030)
Condition: Nausea; Vomiting
MeSH terms: Vomiting
Intervention: Fosaprepitant dimeglumine; 5-HT3 RA; Dexamethasone; Rescue medication
Intervention description: Fosaprepitant 150 mg, IV on Day 1 of chemotherapy in Cycle 2; 5-HT3 RA will be administered at the same dosage in Cycle 2 of chemotherapy as was used for each particpant in Cycle 1 of chemotherapy.; Dexamethasone will be administered at the same dosage in Cycle 2 of chemotherapy as was used for each particpant in Cycle 1 of chemotherapy.; Rescue medication is defined as any medication used to relieve the symptoms of established nausea or vomiting. Multiple medications are permitted by the protocol and may be taken by the participant, including 5-HT3 antagonists, phenothiazines and benzodiazepines.
Intervention MeSH terms: Dexamethasone; Fosaprepitant; Aprepitant
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 111.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess the efficacy of a single dose of intravenous (IV) fosaprepitant
      (MK-0517, EMEND® IV) as salvage therapy when added to a 5-hydroxytryptamine receptor 3
      antagonist (5-HT3 RA) and dexamethasone for the prevention of chemotherapy-induced vomiting
      (CIV) in participants who experienced CIV in the first cycle of moderately emetic
      chemotherapy (MEC). The primary hypothesis is that there will be no vomiting and no retching
      in at least 20% of participants during the second cycle of MEC in participants who previously
      experienced vomiting during the first cycle of MEC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with either breast or gynecological cancer

          -  Receiving either AC-like or CT MEC

          -  Experienced at least 1 episode of vomiting or retching during the first 5 days
             following Cycle 1 of chemotherapy that was thought to be due to chemotherapy. Received
             standard chemotherapy-induced nausea and vomiting (CINV) prophylaxis not containing
             aprepitant or fosaprepitant

          -  No change in chemotherapy at Cycle 2

          -  No change in Cycle 1 antiemetic regimen at Cycle 2

          -  Eastern Cooperative Oncology Group (ECOG) status 0-1

        Exclusion Criteria:

          -  Requires increase in systemic corticosteroid therapy

          -  Used benzodiazepines or opiates in the 48 hours prior to Cycle 2 chemotherapy

          -  Received or will receive radiation therapy to the abdomen or pelvis in the week prior
             to Visit 1 or in Days 1-6 following chemotherapy

          -  Vomited in the 24 hours prior to Treatment Day 1

          -  Pregnant or breast-feeding

          -  Participating in a study with aprepitant or fosaprepitant or has taken an
             investigational drug in the last 4 weeks

          -  Symptomatic central nervous system metastasis

          -  History of other malignancies in the last 2 years