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

NCT ID: NCT02400866

Last Updated: 2015-03-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-04-30

Brief 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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control

palonosetron + dexamethasone + placebo

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Experimental

palonosetron + dexamethasone + olanzapine

Group Type: EXPERIMENTAL

Olanzapine

Intervention Type: DRUG

Interventions

Olanzapine

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korean South West Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Hwan Jung Yun

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jooyoung Lee

Role: CONTACT

poppoya99@naver.com

82-42-280-7399

Other Identifiers

KSWOG 15-01

Identifier Type: -

Identifier Source: org_study_id