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

NCT02400866 | Unknown Phase 2

• 1 other identifier: KSWOG 15-01
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

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

Keywords

cancer patients receiving moderately emetogenic chemotherapy

Outcome Measures

Primary Outcomes (1)

• complete response rate for the acute phase (0-24 hours) after chemotherapy

  during 24 hours after first cycle of moderately emetogenic chemotherapy (MEC)

Secondary Outcomes (5)

• 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

Study Arms (2)

Control

PLACEBO COMPARATOR

palonosetron + dexamethasone + placebo

Experimental

EXPERIMENTAL

palonosetron + dexamethasone + olanzapine

Drug: Olanzapine

Interventions

Olanzapine DRUG

Experimental

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korean South West Oncology Group: lead

MeSH Terms

Conditions

Neoplasms

Interventions

Olanzapine

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Jooyoung Lee

CONTACT

82-42-280-7399; poppoya99@naver.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: March 27, 2015
• Study Start: May 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: April 1, 2017
• Last Updated: March 27, 2015

Record last verified: 2015-03