Clinical trial NCT01432015: Fosaprepitant Versus Aprepitant in the Prevention of Chemotherapy Induced Nausea and Vomiting
Official title: A Phase IV Study Comparing the Efficacy of Fosaprepitant to Aprepitant for Chemotherapy Induced Nausea and Vomiting in Patients Treated for Gynecological Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ovarian Cancer
Uterine Cancer
Keywords: aprepitant
fosaprepitant
gynecologic cancer
emesis
Lead sponsor: Gynecologic Oncology Associates
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-09-12
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 chemotherapy induced nausea and vomiting (CINV) following treatment with carboplatin and paclitaxel. The successful control of chemotherapy induced nausea and vomiting (CINV) is thus, of paramount importance in ensuring optimal treatment and sustaining a cancer patient's quality of life.

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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Overall Complete Response Rate
timeFrame: 13 months
Secondary outcomes:
measure: Impact on Daily Living Activities
timeFrame: 13 months
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Gynecologic Oncology Associates
state: California
Study officials:
affiliation: Gynecologic Oncology Associates
name: John P Micha, MD
role: PRINCIPAL_INVESTIGATOR
References: