Alliance A221602

Clinical Trial Title Olanzapine with or without fosaprepitant for the prevention of chemotherapy induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy (HEC): A Phase III Randomized, Double Blind, Placebo-Controlled Trial.
Trial Status Closed to Enrollment
Start Date 10/15/2018
Location Doctors & Locations
Trial Type Cancer - Adult Oncology
Specific Condition
This randomized phase III trial studies how well olanzapine with or without fosaprepitant work in preventing chemotherapy induced nausea and vomiting in cancer patients receiving chemotherapy that causes vomiting. Olanzapine and fosaprepitant dimeglumine may help control nausea and vomiting in patients during chemotherapy. Olanzapine is usually given in combination with other drugs, including fosaprepitant dimeglumine. It is not yet known if olanzapine when given with other drugs, is still effective without using fosaprepitant dimeglumine for controlling nausea and vomiting.
Eligibility Criteria

Eligibility Criteria

  • Diagnosis of malignant disease of any stage. (Stage I through Stage IV)
  • No prior history of chemotherapy for any malignancy
  • Scheduled to receive intravenous HEC (Highly Emetogenic Chemotherapy) (either cisplatin-containing regimen or doxorubicin and cyclophosphamide [AC]).
  •     Cisplatin, given on a single day, at a dose of ≥ 70 mg/m2, with or without other chemotherapy agent(s)
  •     Doxorubicin (60 mg/m2) plus cyclophosphamide (600 mg/m2)
  • No known history of CNS disease (e.g. seizure disorder).
  • ECOG Performance Status 0, 1 or 2

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

IRB Number Central IRB
Principal Investigator Regan Look, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail