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

• Status: Active, not recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Aprepitant; BB 1101; Dexamethasone; Dexamethasone acetate; Emetics; Fosaprepitant; Olanzapine; Ondansetron; Palonosetron

Criteria

Inclusion 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/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