Cancer
Conditions
Keywords
cancer patients receiving moderately emetogenic chemotherapy
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.
Interventions
DRUGOlanzapine
Sponsors
Korean South West Oncology Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete response rate for the acute phase (0-24 hours) after chemotherapy | during 24 hours after first cycle of moderately emetogenic chemotherapy (MEC) |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Contacts
Primary ContactJooyoung Lee
Outcome results
None listed