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

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ClinicalTrials.gov Identifier: NCT03478605
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : July 4, 2018
Sponsor:
Collaborator:
RUSSCO/RakFond
Information provided by (Responsible Party):
Alexey Rumyantsev, Blokhin's Russian Cancer Research Center

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

Condition or disease Intervention/treatment Phase
Emesis Vomiting Nausea Post Chemotherapy Nausea Chemotherapy-induced Nausea and Vomiting Drug: Olanzapine Drug: Aprepitant Pill Drug: Ondansetron Drug: Dexamethasone Phase 2

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase II randomized trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Randomized Trial to Evaluate Efficacy of Olanzapine With Short-acting 5HT3 Inhibitors in Chemotherapy-induced Nausea & Vomiting (CINV) Prophylaxis
Actual Study Start Date : May 25, 2018
Estimated Primary Completion Date : May 25, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Olanzapine
Olanzapine 5 mg/day p.o. d 0-4 + ondansetron 16 mg IV d 1 + dexamethasone 12 mg IV d 1, 8 mg b.i.d.; IM or P.O. d 2-4;
Drug: Olanzapine
Olanzapine 5 mg/day will be administered orally on days 0-4 of chemotherapy cycle (before bedtime)
Other Name: Zyprexa

Drug: Ondansetron
Ondansetron 16 mg IV on day 1 of chemotherapy cycle (as standard component of antiemetic therapy)

Drug: 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)

Active Comparator: Aprepitant
Aprepitant 125 mg p.o d 1 + 80 mg p.o d 2,3 + ondansetron 16 mg IV d 1 + dexamethasone 12 mg IV d 1, 8 mg b.i.d. IM or P.O. d 2-4;
Drug: Aprepitant Pill
Aprepitant 125 mg orally will be administered on day 1 of chemotherapy cycle; 80 mg - on days 2 and 3.
Other Name: Emend

Drug: Ondansetron
Ondansetron 16 mg IV on day 1 of chemotherapy cycle (as standard component of antiemetic therapy)

Drug: 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)




Primary Outcome Measures :
  1. Nausea control [ Time Frame: 0-120 hours after chemotherapy ]
    Complete control of nausea (ie, no nausea) in overall treatment period (0-120 hours after chemotherapy).


Secondary Outcome Measures :
  1. Complete Response Rate in Overall Treatment Period [ Time Frame: 0-120 hours after chemotherapy ]
    Complete response rate (ie, no vomiting, no use of rescue medication) in 0-120 hours after chemotherapy

  2. Rate of undesired sedation [ Time Frame: 0-120 hours after chemotherapy ]
    Rate of undesired sedation 0-120 hours after chemotherapy

  3. Complete Response Rate in Acute Treatment Period [ Time Frame: 0-24 hours after chemotherapy ]
    Complete response rate (ie, no vomiting, no use of rescue medication) in 0-24 hours after chemotherapy

  4. Complete Response Rate in Delayed Treatment Period [ Time Frame: 24-120 hours after chemotherapy ]
    Complete response rate (ie, no vomiting, no use of rescue medication) in 24-120 hours after chemotherapy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03478605


Contacts
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Contact: Alexey A Rumyantsev, MD +79100022255 alexeymma@gmail.com

Locations
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Russian Federation
N.N. Blokhin Cancer Research Center Recruiting
Moscow, Russian Federation, 115478
Contact: Alexey A Rumyantsev, MD    +79100022255    alexeymma@gmail.com   
Principal Investigator: Alexey A Rumyantsev, MD         
Principal Investigator: Ilya A Pokataev, MD         
Sponsors and Collaborators
Blokhin's Russian Cancer Research Center
RUSSCO/RakFond

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Responsible Party: Alexey Rumyantsev, MD, Blokhin's Russian Cancer Research Center
ClinicalTrials.gov Identifier: NCT03478605     History of Changes
Other Study ID Numbers: OlaCINV
2018-01-YS-ECI ( Other Grant/Funding Number: RUSSCO/RakFond )
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alexey Rumyantsev, Blokhin's Russian Cancer Research Center:
olanzapine
aprepitant
CINV
nausea
vomiting
nausea and vomiting
antiemetics

Additional relevant MeSH terms:
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Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone
Dexamethasone acetate
Ondansetron
Olanzapine
Aprepitant
Fosaprepitant
Antiemetics
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents