A Phase IV Study Comparing the Efficacy of Fosaprepitant to Aprepitant for Chemotherapy Induced Nausea and Vomiting in Patients Treated for Gynecological Cancer

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)