Fosaprepitant Versus Aprepitant in the Prevention of Chemotherapy Induced Nausea and Vomiting

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01432015
• Other study ID #: GOA-NVM1
• Status: Completed
• Phase: Phase 4
• First received: September 7, 2011
• Last updated: May 22, 2015
• Start date: September 2011
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Gynecologic Oncology Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Ovarian Cancer
• Uterine Cancer
• Uterine Neoplasms

Intervention

Drug:
• fosaprepitant
Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. Patient will receive standard pre-medications
• aprepitant
Aprepitant 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3. patient will receive standard pre-medications

Other:
• Oral Placebo
One pill administered on days 1-3 in conjunction with Fosaprepitant.
• IV placebo
100 cc of IV placebo administered on day in conjunction with Aprepitant

Locations

Country	Name	City	State
United States	Gynecologic Oncology Associates	Newport Beach	California

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Associates	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Complete Response Rate	no emetic episodes or rescue therapy following the initiation of chemotherapy	13 months	No
Secondary	Impact on Daily Living Activities	Proportion of patients reporting no impact on daily living activities following initiation of chemotherapy	13 months	No