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Aprepitant or Fosaprepitant in Combination with Dexamethasone and Ondansetron in Preventing Nausea and Vomiting in Patients with Cancer Receiving Carboplatin-Based Chemotherapy

Trial Status: Active

This phase II trial studies how well aprepitant or fosaprepitant in combination with dexamethasone and ondansetron work in preventing nausea and vomiting in patients with cancer receiving carboplatin-based chemotherapy. Giving aprepitant or fosaprepitant in addition to standard anti-nausea medications such as dexamethasone and ondansetron may help control nausea and vomiting better compared to in dexamethasone and ondansetron alone in patients receiving carboplatin-based chemotherapy.

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
  • Patients receiving radiotherapy within 5 days prior to the carboplatin
  • Pregnancy or lactation
  • Known allergy to any of the 3 antiemetics

New York

Bronx
Montefiore Medical Center-Weiler Hospital
Status: ACTIVE
Contact: Richard J. Gralla
Phone: 718-918-6235

PRIMARY OBJECTIVES:

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).

SECONDARY OBJECTIVES:

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.

OUTLINE:

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

Lead Organization
Montefiore Medical Center-Weiler Hospital

Principal Investigator
Richard J. Gralla

  • Primary ID 2015-5109
  • Secondary IDs NCI-2019-02941
  • Clinicaltrials.gov ID NCT03237611