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

Korean South West Oncology Group

Status and phase

Unknown

Phase 2

Conditions

Cancer

Treatments

Drug: Olanzapine

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT02400866

KSWOG 15-01

Details and patient eligibility

About

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.

Enrollment

58 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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