Fosaprepitant Versus Aprepitant in the Prevention of Chemotherapy Induced Nausea and Vomiting
Condition: Ovarian Cancer; Uterine Cancer
MeSH terms: Uterine Neoplasms; Vomiting
Intervention: fosaprepitant; aprepitant; Oral Placebo; IV placebo
Intervention description: Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. Patient will receive standard pre-medications; Aprepitant 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3. patient will receive standard pre-medications; One pill administered on days 1-3 in conjunction with Fosaprepitant.; 100 cc of IV placebo administered on day in conjunction with Aprepitant
Intervention MeSH terms: Aprepitant; Fosaprepitant
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 20.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: aprepitant; fosaprepitant; gynecologic cancer; emesis

Summary:

      Nausea and vomiting are two of the more concerning adverse outcomes associated with
      chemotherapy in the treatment of gynecologic malignancies. In fact, nearly 90% of cancer
      patients develop chemotherapy induced nausea and vomiting (CINV) following treatment with
      carboplatin and paclitaxel. The successful control of chemotherapy induced nausea and
      vomiting (CINV) is thus, of paramount importance in ensuring optimal treatment and sustaining
      a cancer patient's quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female Gender

          -  Age > 18 years

          -  A histologic diagnosis of stage III/IV gynecologic cancer (e.g., epithelial ovarian,
             fallopian tube, peritoneal cancer and uterine cancer).

          -  Subjects who will be treated with Taxol and Carboplatin as standard of care for a
             newly diagnosed gynecological cancer.

          -  Adequate bone marrow function as demonstrated by:

        Absolute neutrophil count (ANC) > 1,500/μL; platelet count > 100,000/μL; and hemoglobin > 9
        g/dL • Adequate renal function demonstrated by: Serum creatinine of < 1.5 x ULN or 24-hr
        measured urine creatinine clearance > 60 mL/min for patients with serum creatinine > 1.5 x
        ULN

        • Adequate hepatic function demonstrated by: Total bilirubin of < 1.5 x ULN AST or ALT ≤
        2.5 x ULN

          -  EGOG status of < 2: Postoperatively, patients demonstrate an ECOG score of 1 or 2.
             However, during the first cycle of chemotherapy, the patients' performance status
             improves to < 1.

          -  Projected life expectancy of at least 3 months

          -  Ability to comply with the visit schedule and assessments required by the protocol

          -  Negative pregnancy test for women of childbearing potential

          -  Signed, IRB approved informed consent and HIPPA consent

        Exclusion Criteria:

          -  Subjects with a diagnosis of epithelial ovarian, fallopian tube or peritoneal cancers
             of low malignant potential (borderline carcinomas) are not eligible.

          -  Allergy or intolerance to 5HT3 or NK-1 antagonists and dexamethasone

          -  An episode of vomiting or retching within 24 hours before the start of the initial
             treatment with chemotherapy

          -  Subjects with concomitant malignancy or a previous malignancy within the past three
             (3) years (except non-melanoma skin cancer)

          -  Current, recent (within 4 weeks of the first infusion of this study), or planned
             participation in an experimental drug study.

          -  Screening clinical laboratory values of:

        ANC of <1500/DL Platelet count of <100,000/µL Total bilirubin of *1.5 mg/dL x ULN SGOT
        (AST) or SGPT (ALT) * 2.5 x ULN Serum creatinine of * 1.5 mg/dL Hemoglobin of * 9 gm/dL
        (may be transfused or receive a colony stimulating factor to maintain or exceed this level)

          -  EGOG status of > 2

          -  Gastrointestinal obstruction or an active peptic ulcer

          -  Patients who are pregnant or breast feeding because aprepitant may be harmful to the
             developing fetus and newborn

          -  Known active HIV and viral hepatitis infections

          -  Inability to comply with study

          -  New York Heart Association (NYHA) Grade II or greater congestive heart failure (see
             Appendix D)