Proof-of-Concept Trial of Palonosetron and Olanzapine Without Dexamethasone for the Prevention of CIN

Proof-of-Concept Trial of Palonosetron and Olanzapine Without Dexamethasone for the Prevention of Chemotherapy-Induced Nausea and Vomiting

The purpose of this study is to determine whether Palonosetron and Olanzapine without dexamethasone for the Prevention of moderate risk Chemotherapy-Induced Nausea and vomiting.

This study was designed to evaluate efficacy and safety of olanzapine compared with 5-hydroxytryptamine3 receptor antagonist for prevention of moderate risk chemotherapy induced nausea and vomiting.

Inclusion Criteria:

• European Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• no severe cognitive compromise
• Moderate risk chemotherapy induced chemotherapy induced nausea and vomiting in 1st cycle
• Confirmed histology

Exclusion Criteria:

• European Cooperative Oncology Group (ECOG) performance status of 3 and 4
• Nausea or vomiting in the 24 hours before enrollment
• History of Nausea or vomiting Grade 3 before previous chemotherapy
• Known history of central nervous system disease (e.g., brain metastases or a seizure disorder)
• Bowel obstruction
• Serum creatinine level of 2.0 mg per deciliter (177 μmol per liter) or more
• Aspartate or alanine aminotransferase level that was more than 3 times the upper limit of the normal range
• Treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, a phenothiazine, or a butyrophenone within 30 days before enrollment
• Treatment with another antiemetic agent before 48 hours before enrollment
• Uncontrolled severe infection or uncontrolled severe comorbidity
• Concurrent abdominal radiotherapy
• Known hypersensitivity to olanzapine, palonosetron
• Known cardiac arrhythmia, uncontrolled congestive heart failure, or acute myocardial infarction within the previous 6 month