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Alliance A221602

Trial

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

October 14, 2018

Trial Type

Cancer - Adult Oncology

Description

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 Name

Regan Look, MD

Contact Name

Oncology Clinical Research

Phone

503-413-8199

Contact Fax

503-413-6920

Contact E-Mail

oncologyresearch@lhs.org

Last Updated: Wednesday, January 27, 2021 12:56:56 PM