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

Cancer Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02400866
• Other study ID #: KSWOG 15-01
• Status: Not yet recruiting
• Phase: Phase 2
• First received: March 24, 2015
• Last updated: March 26, 2015
• Start date: May 2015
• Est. completion date: April 2017

Study information

• Verified date: March 2015
• Source: Korean South West Oncology Group
• Contact: Jooyoung Lee
• Phone: 82-42-280-7399
• Email: poppoya99[@]naver.com
• Is FDA regulated: No
• Health authority: South Korea: Korean Food and Aministration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: April 2017
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• Olanzapine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Korean South West Oncology Group

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete response rate for the acute phase (0-24 hours) after chemotherapy		during 24 hours after first cycle of moderately emetogenic chemotherapy (MEC)	Yes
Secondary	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	Yes
Secondary	no vomiting for the overall phase		during 0-120 hours after first cycle of MEC	Yes
Secondary	significant emesis for the overall phase		during 0-120 hours after first cycle of MEC	Yes
Secondary	numbers and time for rescue medicaions		during 0-120 hours after first cycle of MEC	Yes
Secondary	effects on quality of life by FLIE questionnaire		during 0-120 hours after first cycle of MEC	Yes