Trial to Evaluate Efficacy of Olanzapine With Short-acting 5HT3 Inhibitors in Chemotherapy-induced Nausea & Vomiting (CINV) Prophylaxis

Nausea Clinical Trial

— OlaCINV  

Official title:

Phase II Randomized Trial to Evaluate Efficacy of Olanzapine With Short-acting 5HT3 Inhibitors in Chemotherapy-induced Nausea & Vomiting (CINV) Prophylaxis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03478605
• Other study ID #: OlaCINV
• Secondary ID: 2018-01-YS-ECI
• Status: Recruiting
• Phase: Phase 2
• Start date: May 25, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: July 2018
• Source: Blokhin's Russian Cancer Research Center
• Contact: Alexey A Rumyantsev, MD
• Phone: +79100022255
• Email: alexeymma[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Olanzapine-containing regimens for CINV prophylaxis may provide even better protection than aprepitant-containing regimens.

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 but cheaper. However, there is no strong evidence supporting the advantages of olanzapine over aprepitant - and this is the reason why aprepitant is still the standard of care. Due to high cost aprepitant can be not affordable in low- and middle income countries; this compromises quality of life of cancer patients. On the other hand, recommended olanzapine-based regimen includes palonosetron, whose price is quite high as well and undesired sedation is a common side effect for olanzapine doses that currently recommended, these adverse events precludes wide use of olanzapine in oncology. Development of effective, tolerable and affordable regimen for CINV prophylaxis based on low-dose olanzapine and short-acting 5-HT3 inhibitors can improve quality of care for many cancer patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: June 1, 2019
• Est. primary completion date: May 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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);

2. Administration of HEC component only in first day of the cycle;

3. No previous chemotherapy or radiotherapy;

4. No concomitant quinolone antibiotics administration;

5. ECOG PS =2;

6. No nausea and vomiting 24 hours before enrollment;

7. Adequate hepatic and renal function (eg, ALaT, ASaT =3 ULN, creatinine clearance =50 ml/minute).

8. No brain metastases, leptomeningeal carcinomatosis, and chronic diseases such as uncontrolled diabetes mellitus and chronic alcohol consumption.

9. Subject willing to participate in the trial and provided informed consent form.

Exclusion Criteria:

1. Previous chemotherapy or radiotherapy;

2. Moderate- or low- emetogenic chemotherapy;

3. Multiday administration of HEC agents;

4. ECOG PS >2;

5. History of brain metastases, signs of symptoms of bowel obstruction;

6. Nausea and/or vomiting of any genesis 24 hours before enrollment;

7. Uncontrolled diabetes mellitus or other metabolic diseases; chronic alcohol consumption.

8. Diseases and conditions interfere with subject ability to swallow the drug and to take oral medication;

9. Concomitant therapy with olanzapine or other antipsychotic drugs; history of mental illness;

10. Concomitant therapy with quinolone antibiotics;

11. Contraindications for olanzapine or aprepitant administration;

12. Intraperitoneal or intrapleural administration of HEC drugs;

13. Inadequate hepatic and/or renal function.

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting
• Emesis
• Nausea
• Nausea Post Chemotherapy
• Vomiting

Intervention

Drug:
• Olanzapine
Olanzapine 5 mg/day will be administered orally on days 0-4 of chemotherapy cycle (before bedtime)
• Aprepitant Pill
Aprepitant 125 mg orally will be administered on day 1 of chemotherapy cycle; 80 mg - on days 2 and 3.
• Ondansetron
Ondansetron 16 mg IV on day 1 of chemotherapy cycle (as standard component of antiemetic therapy)
• Dexamethasone
Dexamethasone 8 mg IV on day 1 of chemotherapy cycle; 8 mg IV or orally on days 2-3 (as standard component of antiemetic therapy)

Locations

Country	Name	City	State
Russian Federation	N.N. Blokhin Cancer Research Center	Moscow

Sponsors (2)

Lead Sponsor	Collaborator
Blokhin's Russian Cancer Research Center	RUSSCO/RakFond

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nausea control	Complete control of nausea (ie, no nausea) in overall treatment period (0-120 hours after chemotherapy).	0-120 hours after chemotherapy
Secondary	Complete Response Rate in Overall Treatment Period	Complete response rate (ie, no vomiting, no use of rescue medication) in 0-120 hours after chemotherapy	0-120 hours after chemotherapy
Secondary	Rate of undesired sedation	Rate of undesired sedation 0-120 hours after chemotherapy	0-120 hours after chemotherapy
Secondary	Complete Response Rate in Acute Treatment Period	Complete response rate (ie, no vomiting, no use of rescue medication) in 0-24 hours after chemotherapy	0-24 hours after chemotherapy
Secondary	Complete Response Rate in Delayed Treatment Period	Complete response rate (ie, no vomiting, no use of rescue medication) in 24-120 hours after chemotherapy	24-120 hours after chemotherapy