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 anewly diagnosed gynecological cancer.

• Adequate bone marrow function as demonstrated by: Absolute neutrophil count (ANC) > 1,500/μL; platelet count > 100,000/μL; and hemoglobin > 9g/dL • Adequate renal function demonstrated by: Serum creatinine of < 1.5 x ULN or 24-hrmeasured urine creatinine clearance > 60 mL/min for patients with serum creatinine > 1.5 xULN

• 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 statusimproves 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 cancersof 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 initialtreatment 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 plannedparticipation 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 thedeveloping 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 (seeAppendix D)