Low Dose Aprepitant for Patients Receiving Carboplatin

Stopped early · Phase 2

Conditions studied: Chemotherapy-induced Nausea and Vomiting

In brief

This study evaluates a simple one day prophylaxis of nausea and vomiting for patients who are getting carboplatin based chemotherapy. In addition to standard oral Dexamethasone and oral Ondansetron, participants will be given a third neurokinin 1 (NK1) antagonist agent, either a single dose of oral Aprepitant or intravenous (IV) Fosaprepitant (they have been shown to be equally effective) to improve prevention of nausea and vomiting. No medications need to be taken beyond day 1.

Key facts

Study ID

NCT03237611

Run by

Albert Einstein College of Medicine

People needed

15

Starts

2018-10-30

Expected to finish

2021-02-11

Last updated by the study team

2023-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• No prior chemotherapy
• Confirmed malignancy, scheduled to receive carboplatin monotherapy, or carboplatin in combination with agents of minimal, low, or moderate emetic potential
• Laboratory parameters adequate for chemotherapy

You may not qualify if…

• Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 3 or 4
• Presence of nausea and vomiting or use of major antiemetic agents during the 24 hours before chemotherapy administration
• Patients receiving radiotherapy within 5 days prior to the carboplatin
• Pregnancy or lactation
• Known allergy to any of the 3 antiemetics

Where it is running

• Jacobi Medical Center — The Bronx, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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