A Randomized Study of Olanzapine for the Prevention of CINV in Patients Receiving Moderately Emetogenic Chemotherapy

Study Overview
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Brief Summary
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This aim of study is to evaluate the safety and efficacy of olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy by a randomized, double-blind, placebo-controlled trial.

Conditions
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Cancer

Intervention / Treatment
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* Drug: Olanzapine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: over 19 years of age no history of receiving moderately or highly emetogenic chemotherapy during last 6 months, and is to receive a first course of MEC including one or more of following agents: Carboplatin, Cyclophosphamide ≤ 1,500 mg/m2, Daunorubicin, Doxorubicin < 60 mg/m2, Epirubicin ≤ 90 mg/m2, Irinotecan, Oxaliplatin, Melphalan, Methotrexate ≥ 250 mg/m2 ECOG performance status 0-2 predicted life expectancy ≥ 3 months adequate bone marrow, kidney, and liver functionas evidenced by: ANC ≥ 1,500/mm3, platelet count ≥ 100,000/mm3, total bilirubine ≤ 2 x ULN, AST ≤ 3 x ULN, ALT ≤ 3 x ULN (for subjects with known liver metastases, total bilirubin ≤ 3 x ULN, AST ≤ 5 x ULN, ALT ≤ 5 x ULN), Creatinine ≤ 1.5 x ULN or Ccr ≥ 50 ml/min no episodes of nausea and vomiting during last 24 hours before enrollment subjects provides written informed consent Exclusion criteria: subjects with uncontrolled neuro-psychiatric disease (alcohol abuse, seizure, psychosis etc) except malignant tumor subject is scheduled to receive highly emetogenic chemotherapeutic agents: Doxorubicin or Epirubicin + cyclophosphamide, Cisplatin ≥ 50 mg/m2, Carmustine > 250 mg/m2, Cisplatin ≥ 50 mg/m2, Cyclophosphamide > 1,500 mg/m2, Dacarbazine, Doxurubicine ≥ 60 mg/m2, Epirubicine > 90 mg/m2, Ifosfamide ≥ 2 g/m2 per dose, Mechlorethamine, Streptozocin contraindication to the administration of palonosetron, dexamethasone, and olanzapine due to hypersensitivity or any other reasons subject has severe cognitive impairment subjects has symptomatic or uncontrolled brain metastasis or brain tumor female subjects of childbearing potential who dose not agree to use a proper contraceptive methods or to limit breast feeding subject has taken the following agents: risperidone, quetiapine, clozapine, phenothiazine, butyrophenone, 5-HT3 antagonist, bezamides, domperidone, cannabinoids, NK1 antagonist, bezodiazepines subject has a plan to receive other chemotherapy, abdomial radiation, surgery, or immunotherapy any history of arrhythmia, uncontrolled congestive heart failure, acute myocardial infarction durting last 6 months history of uncontrolled diabetes subject who has used any investigational drugs within 30 days of randomization

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>palonosetron + dexamethasone + placebo | |
| Experimental: Experimental<br>palonosetron + dexamethasone + olanzapine | Drug: Olanzapine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete response rate for the acute phase (0-24 hours) after chemotherapy |  | during 24 hours after first cycle of moderately emetogenic chemotherapy (MEC) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete response rate for the delayed phase (24-120 hours) and overall phase (0-120 hours) after chemotherapy |  | during 0-120 hours after first cycle of MEC | 
| no vomiting for the overall phase |  | during 0-120 hours after first cycle of MEC | 
| significant emesis for the overall phase |  | during 0-120 hours after first cycle of MEC | 
| numbers and time for rescue medicaions |  | during 0-120 hours after first cycle of MEC | 
| effects on quality of life by FLIE questionnaire |  | during 0-120 hours after first cycle of MEC | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer patients receiving moderately emetogenic chemotherapy