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

NCT ID: NCT01432015

Last Updated: 2017-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2015-03-31

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.

Conditions

Ovarian Cancer; Uterine Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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. Oral Placebo given on days 1-3

Group Type: ACTIVE_COMPARATOR

fosaprepitant

Intervention Type: DRUG

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

Oral Placebo

Intervention Type: OTHER

One pill administered on days 1-3 in conjunction with Fosaprepitant.

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. 100 cc of IV placebo administered on day 1

Group Type: ACTIVE_COMPARATOR

aprepitant

Intervention Type: DRUG

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

IV placebo

Intervention Type: OTHER

100 cc of IV placebo administered on day in conjunction with Aprepitant

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Oral Placebo

One pill administered on days 1-3 in conjunction with Fosaprepitant.

Intervention Type: OTHER

IV placebo

100 cc of IV placebo administered on day in conjunction with Aprepitant

Intervention Type: OTHER

Other Intervention Names

Emend IV; Emend; Normal Saline

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Gynecologic Oncology Associates

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John P Micha, MD

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Associates

Locations

Gynecologic Oncology Associates

Newport Beach, California, United States

Countries

United States

Other Identifiers

GOA-NVM1

Identifier Type: -

Identifier Source: org_study_id