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

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.

Study Overview

• Status: Unknown
• Conditions: Cancer
• Intervention / Treatment: Drug: Olanzapine

• Study Type: Interventional
• Enrollment (Anticipated): 58
• Phase: Phase 2

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; palonosetron + dexamethasone + placebo
Experimental: Experimental; palonosetron + dexamethasone + olanzapine	Drug: Olanzapine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Korean South West Oncology Group

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): November 1, 2015
• Study Completion (Anticipated): April 1, 2017

Study Registration Dates

• First Submitted: March 24, 2015
• First Submitted That Met QC Criteria: March 26, 2015
• First Posted (Estimate): March 27, 2015

Study Record Updates

• Last Update Posted (Estimate): March 27, 2015
• Last Update Submitted That Met QC Criteria: March 26, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: cancer patients receiving moderately emetogenic chemotherapy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Olanzapine
• Other Study ID Numbers: KSWOG 15-01