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

Phase 4
18 Years
Open (Enrolling)
Ovarian Cancer, Uterine Cancer

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Trial Information

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

Studies have indicated that oral and intravenous anti-emetics are equivalent with regard to
efficacy; when evaluating cost and convenience, the intravenous route may be preferable.
Fosaprepitant, a water-soluble phosphoryl prodrug for aprepitant, is converted to aprepitant
via phosphatases following intravenous administration. Given the rapid conversion of
fosaprepitant to the active form (i.e., aprepitant), the two medications appear to provide a
similarly effective antiemetic impact. Clinical reports have additionally suggested that
fosaprepitant could be appropriate as an intravenous alternative to the oral aprepitant.

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

- 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)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Proportion of patients reporting no vomiting during the five days following initiation of chemotherapy

Outcome Time Frame:

13 months

Safety Issue:


Principal Investigator

John P Micha, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Associates


United States: Institutional Review Board

Study ID:




Start Date:

September 2011

Completion Date:

December 2012

Related Keywords:

  • Ovarian Cancer
  • Uterine Cancer
  • aprepitant
  • fosaprepitant
  • gynecologic cancer
  • emesis
  • Ovarian Neoplasms
  • Uterine Neoplasms
  • Vomiting



Gynecologic Oncology AssociatesNewport Beach, California  92663