Status:
UNKNOWN
Trial to Evaluate Efficacy of Olanzapine With Short-acting 5HT3 Inhibitors in Chemotherapy-induced Nausea & Vomiting (CINV) Prophylaxis
Lead Sponsor:
Blokhin's Russian Cancer Research Center
Collaborating Sponsors:
RUSSCO/RakFond
Conditions:
Emesis
Vomiting
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Olanzapine-containing regimens for CINV prophylaxis may provide even better protection than aprepitant-containing regimens.
Detailed Description
Olanzapine-containing regimens for CINV provide high complete response (CR) rate in patients receiving high emetogenic chemotherapy. Olanzapine may be more effective than aprepitant in this setting bu...
Eligibility Criteria
Inclusion
- High-emetogenic chemotherapy (HEC) regimen (e.g., cisplatin ≥70 mg/m2 or doxorubicin ≥60 mg/m2 or carboplatin AUC≥4). Patients that are prescribed less doses of mentioned agents are still allowed if another high-emetogenic drug will be administered (eg, doxorubicin plus cisplatin);
- Administration of HEC component only in first day of the cycle;
- No previous chemotherapy or radiotherapy;
- No concomitant quinolone antibiotics administration;
- ECOG PS ≤2;
- No nausea and vomiting 24 hours before enrollment;
- Adequate hepatic and renal function (eg, ALaT, ASaT ≤3 ULN, creatinine clearance ≥50 ml/minute).
- No brain metastases, leptomeningeal carcinomatosis, and chronic diseases such as uncontrolled diabetes mellitus and chronic alcohol consumption.
- Subject willing to participate in the trial and provided informed consent form.
Exclusion
- Previous chemotherapy or radiotherapy;
- Moderate- or low- emetogenic chemotherapy;
- Multiday administration of HEC agents;
- ECOG PS \>2;
- History of brain metastases, signs of symptoms of bowel obstruction;
- Nausea and/or vomiting of any genesis 24 hours before enrollment;
- Uncontrolled diabetes mellitus or other metabolic diseases; chronic alcohol consumption.
- Diseases and conditions interfere with subject ability to swallow the drug and to take oral medication;
- Concomitant therapy with olanzapine or other antipsychotic drugs; history of mental illness;
- Concomitant therapy with quinolone antibiotics;
- Contraindications for olanzapine or aprepitant administration;
- Intraperitoneal or intrapleural administration of HEC drugs;
- Inadequate hepatic and/or renal function.
Key Trial Info
Start Date :
May 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2019
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT03478605
Start Date
May 25 2018
End Date
June 1 2019
Last Update
July 5 2018
Active Locations (1)
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1
N.N. Blokhin Cancer Research Center
Moscow, Russia, 115478