Phase 3
N=690
Olanzapine With or Without Fosaprepitant Dimeglumine in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Chemotherapy
Malignant Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT03578081 ↗Enrolled (actual)
690
Serious AEs
19.2%
Results posted
May 2023
Primary outcome: Primary: No Nausea Rate Defined as a Response of 0 in the Nausea Item of Nausea and Vomiting Daily Diary/Questionnaire in the Overall (0-120 Hours), Acute (0-24 Hours), and Delayed (24-120 Hours) Periods — 123; 97; 203; 223 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Palonosetron Hydrochloride (Drug); Ondansetron Hydrochloride (Drug); Dexamethasone (Drug); Fosaprepitant Dimeglumine (Drug); Olanzapine (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alliance for Clinical Trials in Oncology
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY No Nausea Rate Defined as a Response of 0 in the Nausea Item of Nausea and Vomiting Daily Diary/Questionnaire in the Overall (0-120 Hours), Acute (0-24 Hours), and Delayed (24-120 Hours) Periods |
123; 97; 203; 223; 202; 201 | — |
| SECONDARY Complete Response (CR) (no Emetic Episodes and no Use of Rescue Medication) During the Acute, Delayed and the Overall Periods as Measured by the Nausea and Vomiting Daily Diary/Questionnaire |
179; 151; 256; 247; 193; 166 | — |
| SECONDARY Potential Toxicities as Ascribed to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire |
140; 136; 186; 184; 235; 236 | — |
| SECONDARY Average Nausea Scores (0-10) Repeatedly Measured by the Nausea and Vomiting Daily Diary/Questionnaire |
0.8211364; 0.9177778 | — |
| SECONDARY Total Frequency of Rescue Medication as Measured by the Nausea and Vomiting Daily Diary/Questionnaire |
3614; 3541; 350; 405; 170; 162 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03578081). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.