Proof-of-Concept Trial of Palonosetron and Olanzapine Without Dexamethasone for the Prevention of CIN

NCT02970643 | Unknown DMC

• 1 other identifier: C2016034
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine whether Palonosetron and Olanzapine without dexamethasone for the Prevention of moderate risk Chemotherapy-Induced Nausea and vomiting.

Conditions

Chemotherapy-induced Nausea and Vomiting

Keywords

Olanzapine; Chemotherapy-Induced Nausea and Vomiting; Moderate risk

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug, Graded According to NCI CTCAE Version 4.0 nausea

  the overall assessment period (0 to 72 hours)

Secondary Outcomes (1)

• Quality of life was evaluated according to MDASI-K

  the overall assessment period (0 to 72 hours)

Study Arms (1)

Olanzapine group

EXPERIMENTAL

Palonosetron and Olanzapine Without Dexamethasone in moderate risk chemotherapy induced nausea and vomiting group

Drug: Olanzapine; Drug: Palonosetron

Interventions

Olanzapine DRUG

Moderate risk chemotherapy induced nausea group in all cancer. D1 Olanzapine 10mg PO D2-3 Olanzapine 10mg PO

Also known as: Zyprexa

Olanzapine group

Palonosetron DRUG

Moderate risk chemotherapy induced nausea group in all cancer. D1 Palonosetron 0.25mg IV

Also known as: Aloxi

Olanzapine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• European Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• no severe cognitive compromise
• Moderate risk chemotherapy induced chemotherapy induced nausea and vomiting in 1st cycle
• Confirmed histology

You may not qualify if:

• European Cooperative Oncology Group (ECOG) performance status of 3 and 4
• Nausea or vomiting in the 24 hours before enrollment
• History of Nausea or vomiting Grade 3 before previous chemotherapy
• Known history of central nervous system disease (e.g., brain metastases or a seizure disorder)
• Bowel obstruction
• Serum creatinine level of 2.0 mg per deciliter (177 μmol per liter) or more
• Aspartate or alanine aminotransferase level that was more than 3 times the upper limit of the normal range
• Treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, a phenothiazine, or a butyrophenone within 30 days before enrollment
• Treatment with another antiemetic agent before 48 hours before enrollment
• Uncontrolled severe infection or uncontrolled severe comorbidity
• Concurrent abdominal radiotherapy
• Known hypersensitivity to olanzapine, palonosetron
• Known cardiac arrhythmia, uncontrolled congestive heart failure, or acute myocardial infarction within the previous 6 month

Sponsors & Collaborators

• Hee Jun Kim: lead
• HK inno.N Corporation: collaborator

Related Publications (8)

• Navari RM, Qin R, Ruddy KJ, Liu H, Powell SF, Bajaj M, Dietrich L, Biggs D, Lafky JM, Loprinzi CL. Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting. N Engl J Med. 2016 Jul 14;375(2):134-42. doi: 10.1056/NEJMoa1515725.

  PMID: 27410922 BACKGROUND

• Tan L, Liu J, Liu X, Chen J, Yan Z, Yang H, Zhang D. Clinical research of Olanzapine for prevention of chemotherapy-induced nausea and vomiting. J Exp Clin Cancer Res. 2009 Sep 23;28(1):131. doi: 10.1186/1756-9966-28-131.

  PMID: 19775450 BACKGROUND

• Naeim A, Dy SM, Lorenz KA, Sanati H, Walling A, Asch SM. Evidence-based recommendations for cancer nausea and vomiting. J Clin Oncol. 2008 Aug 10;26(23):3903-10. doi: 10.1200/JCO.2007.15.9533.

  PMID: 18688059 BACKGROUND

• Lohr L. Chemotherapy-induced nausea and vomiting. Cancer J. 2008 Mar-Apr;14(2):85-93. doi: 10.1097/PPO.0b013e31816a0f07.

  PMID: 18391612 BACKGROUND

• American Society of Clinical Oncology; Kris MG, Hesketh PJ, Somerfield MR, Feyer P, Clark-Snow R, Koeller JM, Morrow GR, Chinnery LW, Chesney MJ, Gralla RJ, Grunberg SM. American Society of Clinical Oncology guideline for antiemetics in oncology: update 2006. J Clin Oncol. 2006 Jun 20;24(18):2932-47. doi: 10.1200/JCO.2006.06.9591. Epub 2006 May 22.

  PMID: 16717289 BACKGROUND

• Navari RM, Gray SE, Kerr AC. Olanzapine versus aprepitant for the prevention of chemotherapy-induced nausea and vomiting: a randomized phase III trial. J Support Oncol. 2011 Sep-Oct;9(5):188-95. doi: 10.1016/j.suponc.2011.05.002. Epub 2011 Sep 24.

  PMID: 22024310 BACKGROUND

• Vardy J, Chiew KS, Galica J, Pond GR, Tannock IF. Side effects associated with the use of dexamethasone for prophylaxis of delayed emesis after moderately emetogenic chemotherapy. Br J Cancer. 2006 Apr 10;94(7):1011-5. doi: 10.1038/sj.bjc.6603048.

  PMID: 16552437 BACKGROUND

• Cleeland CS, Mendoza TR, Wang XS, Chou C, Harle MT, Morrissey M, Engstrom MC. Assessing symptom distress in cancer patients: the M.D. Anderson Symptom Inventory. Cancer. 2000 Oct 1;89(7):1634-46. doi: 10.1002/1097-0142(20001001)89:73.0.co;2-v.

  PMID: 11013380 BACKGROUND

MeSH Terms

Conditions

Vomiting

Interventions

Olanzapine; Palonosetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Isoquinolines

Study Officials

• Heejun Kim, MD.PhD

  Associate Professor

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor,Division of Hemato-oncology

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 22, 2016
• Study Start: July 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 23, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share