Safety and Efficacy of Aprepitant, Ramosetron, and Dexamethasone for Chemotherapy-Induced Nausea and Vomiting in Patients With Ovarian Cancer Treated With Taxane/Carboplatin
Condition: Chemotherapy-Induced Nausea and Vomiting; Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Nausea; Vomiting
Intervention: Aprepitant/Ramosetron/Dexamethasone
Intervention description: Aprepitant: The first day, one 125 mg capsule will be administered per oral, 1 hour before chemotherapy. Thereafter one 80 mg capsule will be repeated daily between 8 to 10 a.m. during days 2 to 3.
Ramosetron: 0.3 mg i.v. a single dose on day 1, administered over 30 seconds, 30 minutes prior to chemotherapy.
Dexamethasone: 20mg diluted in 50ml of 0.9% saline i.v. a single dose on day 1, administered over 30minutes prior to chemotherapy (taxane). Because all patients are premedicated with dexamethasone 20 mg before taxane administration, the dose of dexamethasone can not be reduced to 12 mg.
Intervention MeSH terms: Dexamethasone; Aprepitant; Ramosetron
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 89.0
Sex: Female
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: efficacy and safety of Aprepitant/Ramosetron/Dexamethasone in ovary cancer patients with taxol and carboplatin

Summary:

      The current recommended guideline for patients receiving moderately emetogenic chemotherapy
      (MEC) is the combination of a 5-HT3 receptor antagonist and corticosteroid. Incidence of
      chemotherapy induced nausea and vomiting (CINV) is approximately 50% in patients receiving
      MEC. An incidence rate of 25-38% for delayed emesis and 55-60% for delayed nausea has been
      observed. Hence, there is clearly a need for more effective prevention of CINV in patients
      receiving MEC, especially in women with ovarian carcinoma who are particularly susceptible to
      these symptoms. Therefore the investigators designed a study with the objective to evaluate
      if new combination (Aprepitant/Ramosetron/Dexamethasone) may improve actual CINV control in
      ovarian carcinoma patients treated with taxane/carboplatin.
    

Eligibility criteria:

        Inclusion criteria

          1. patient is over 18 years

          2. ovarian carcinoma patients who are treated with moderately emetogenic chemotherapy

          3. Karnofsky score > 60

          4. Life expectancy > 4 months

        Exclusion criteria

          1. Any of following conditions (mentally incapacitated or emotional or psychiatric
             disorder, user of any illicit drugs, has an active infection, hypersensitivity to
             ramosetron or aprepitant)

          2. Patients have received a nonapproved drug within last 4 weeks

          3. abnormal laboratory values (AST > 2.5 normal, ALT > 2.5 normal, Bilirubin > 1.5
             normal, Creatinine > 1.5 normal)

          4. Antiemetic drugs within 48 hours of study

          5. Benzodiazepine or opiate within 48 hours

          6. CYP3A4 substrates within 7 days (terfenadine, cisapride, astemizole, pimozide)

          7. CYP3A4 inhibitors (clarithromycin, ketoconazole)

          8. CYP3A4 inducers within 30 days (Barbiturates, rifampicin, carbamazepine)