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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
First received
Last updated
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
Health authority
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.

Study Design


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
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