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

• Status: Unknown status
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Korean South West Oncology Group
• Treatments: Olanzapine

Criteria

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