Status:
COMPLETED
Fosaprepitant Versus Aprepitant in the Prevention of Chemotherapy Induced Nausea and Vomiting
Lead Sponsor:
Gynecologic Oncology Associates
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Ovarian Cancer
Uterine Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief 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 chemothera...
Detailed Description
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 wa...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01432015
Start Date
September 1 2011
End Date
March 1 2015
Last Update
March 28 2017
Active Locations (1)
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1
Gynecologic Oncology Associates
Newport Beach, California, United States, 92663