Trial | NCT02970643  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    48
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.
Study Started
Jul 31
2016
Primary Completion
Sep 30
2017
Anticipated
Study Completion
Dec 31
2017
Anticipated
Last Update
Nov 23
2016
Estimate

Drug Olanzapine

Moderate risk chemotherapy induced nausea group in all cancer. D1 Olanzapine 10mg PO D2-3 Olanzapine 10mg PO

  • Other names: Zyprexa

Drug Palonosetron

Moderate risk chemotherapy induced nausea group in all cancer. D1 Palonosetron 0.25mg IV

  • Other names: Aloxi

Olanzapine group Experimental

Palonosetron and Olanzapine Without Dexamethasone in moderate risk chemotherapy induced nausea and vomiting group

Criteria 

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
No Results Posted