NCT01432015

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Gynecologic Oncology Associates · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
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
OTHER	Oral Placebo	One pill administered on days 1-3 in conjunction with Fosaprepitant.
OTHER	IV placebo	100 cc of IV placebo administered on day in conjunction with Aprepitant

Timeline

• Start date: 2011-09-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2011-09-12
• Last updated: 2017-03-28
• Results posted: 2015-05-27

Locations

1 site across 1 country: United States