Olanzapine With or Without Fosaprepitant Dimeglumine in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Chemotherapy

Completed · Phase 3 · Has a placebo group

Conditions studied: Malignant Neoplasm

In brief

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.

Key facts

Study ID

NCT03578081

Run by

Alliance for Clinical Trials in Oncology

People needed

690

Starts

2018-11-20

Expected to finish

2023-05-01

Last updated by the study team

2025-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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/m\^2, with or without other chemotherapy agent(s) OR doxorubicin (60 mg/m\^2) plus cyclophosphamide (600 mg/m\^2)
• No nausea or vomiting =< 24 hours prior to registration
• Negative pregnancy test (serum or urine) done =< 7 days prior to registration, for women of childbearing potential only
• A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
• No known diagnosis of dementia; patients with stable treated brain metastases are eligible to participate
• No known history of central nervous system (CNS) disease (e.g. seizure disorder)
• No treatment with another antipsychotic agent such as olanzapine, risperidone, quetiapine, clozapine, phenothiazine or butyrophenone =< 30 days prior to registration
• No chronic phenothiazine administration as an antipsychotic agent (patients may receive prochlorperazine and other phenothiazines as rescue anti-emetic therapy but not within 24 hours prior to registration)
• No use of amifostine within 7 days prior to registration
• No radiotherapy within 7 days prior to registration or planned for one week after the current dose of chemotherapy
• No use of quinolone antibiotic therapy within 7 days prior to registration
• No chronic alcoholism (as determined by the investigator)
• No known hypersensitivity to olanzapine
• No known uncontrolled cardiac arrhythmia, no known uncontrolled congestive heart failure, or no acute myocardial infarction within the previous six months
• No history of uncontrolled diabetes mellitus, i.e., no diabetic ketoacidosis; within 6 months prior to registration; patients are eligible if they have controlled diabetes on diet, oral agents, and/or insulin
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
• Patients must be able to read and comprehend English; local translation, including verbal translation of patient-reported outcomes (PROs) is not permitted
• Serum creatinine =< 2.0 mg/dL =< 120 days prior to registration
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 3 x upper limit of normal (ULN) =< 120 days prior to registration

Where it is running

• Fairbanks Memorial Hospital — Fairbanks, Alaska, United States
• Kingman Regional Medical Center — Kingman, Arizona, United States
• Mayo Clinic Hospital in Arizona — Phoenix, Arizona, United States
• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• Mercy Hospital Fort Smith — Fort Smith, Arkansas, United States
• Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro, Arkansas, United States
• PCR Oncology — Arroyo Grande, California, United States
• Epic Care-Dublin — Dublin, California, United States
• Bay Area Breast Surgeons Inc — Emeryville, California, United States
• Epic Care Partners in Cancer Care — Emeryville, California, United States
• Tibor Rubin VA Medical Center — Long Beach, California, United States
• Contra Costa Regional Medical Center — Martinez, California, United States
• Alta Bates Summit Medical Center - Summit Campus — Oakland, California, United States
• Bay Area Tumor Institute — Oakland, California, United States
• Desert Regional Medical Center — Palm Springs, California, United States
• Epic Care Cyberknife Center — Walnut Creek, California, United States
• Rocky Mountain Cancer Centers-Aurora — Aurora, Colorado, United States
• The Medical Center of Aurora — Aurora, Colorado, United States
• Boulder Community Hospital — Boulder, Colorado, United States
• Boulder Community Foothills Hospital — Boulder, Colorado, United States
• Rocky Mountain Cancer Centers-Boulder — Boulder, Colorado, United States
• Rocky Mountain Cancer Centers - Centennial — Centennial, Colorado, United States
• Cancer Center of Colorado at Sloan's Lake — Denver, Colorado, United States
• Denver Health Medical Center — Denver, Colorado, United States
• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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