Low Dose Aprepitant for Patients Receiving Carboplatin

• Status: Recruiting
• Trial end date: 2021-08-30
• Target enrollment: 0
• Participant gender: All

Summary

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 dexmethasone and oral ondansetrone, participants will be given a third neurokinin 1 (NK1) antagonist agent, either Aprepitant or 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albert Einstein College of Medicine; Albert Einstein College of Medicine, Inc.
• Collaborator: Jacobi Medical Center
• Treatments: Antiemetics; Aprepitant; BB 1101; Carboplatin; Dexamethasone; Dexamethasone acetate; Fosaprepitant; Ondansetron

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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