Fosaprepitant Versus Aprepitant in the Prevention of Chemotherapy Induced Nausea and Vomiting

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)