Aprepitant or Fosaprepitant in Combination with Dexamethasone and Ondansetron in Preventing Nausea and Vomiting in Patients with Cancer Receiving Carboplatin-Based Chemotherapy
- 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
- 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
- Patients receiving radiotherapy within 5 days prior to the carboplatin
- Pregnancy or lactation
- Known allergy to any of the 3 antiemetics
I. To determine in patients receiving their first cycle of carboplatin-based chemotherapy, the complete control rate of emesis (acute and delayed; no vomiting and no use of rescue medications) with the addition of one dose of the oral aprepitant or intravenous fosaprepitant to a combination of oral dexamethasone + an oral 5-HT3RA (ondansetron).
I. To estimate the control rate on the second cycle of this chemotherapy in those patients agreeing to be assessed in the subsequent chemotherapy cycle.
Patients receive aprepitant orally (PO) or fosaprepitant intravenously (IV) over 20 minutes immediately prior to receiving the first cycle of carboplatin-based chemotherapy. In addition, patients also receive dexamethasone PO and ondansetron PO prior to chemotherapy. Patients may optionally receive aprepitant or fosaprepitant, dexamethasone, and ondansetron during the second cycle of carboplatin-based chemotherapy.
After completion of study treatment, patients are followed up at 1 and 5 days after receiving chemotherapy.
Trial Phase Phase II
Trial Type Supportive care
Montefiore Medical Center-Weiler Hospital
Richard J. Gralla
- Primary ID 2015-5109
- Secondary IDs NCI-2019-02941
- Clinicaltrials.gov ID NCT03237611