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

Chemotherapy-induced Nausea and Vomiting Clinical Trial

Official title:

Proof-of-Concept Trial of Palonosetron and Olanzapine Without Dexamethasone for the Prevention of Chemotherapy-Induced Nausea and Vomiting

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02970643
• Other study ID #: C2016034
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 16, 2016
• Last updated: November 22, 2016
• Start date: July 2016
• Est. completion date: December 2017

Study information

• Verified date: November 2016
• Source: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Description:

This study was designed to evaluate efficacy and safety of olanzapine compared with 5-hydroxytryptamine3 receptor antagonist for prevention of moderate risk chemotherapy induced nausea and vomiting.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 48
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting
• Nausea
• Vomiting

Intervention

Drug:
• Olanzapine
Moderate risk chemotherapy induced nausea group in all cancer. D1 Olanzapine 10mg PO D2-3 Olanzapine 10mg PO
• Palonosetron
Moderate risk chemotherapy induced nausea group in all cancer. D1 Palonosetron 0.25mg IV

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hee Jun Kim	CJ HealthCare Corporation

References & Publications (8)

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. Erratum in: J Clin Oncol. 2006 Nov 20;24(33):5341-2. — View Citation

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. — View Citation

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

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. Review. — View Citation

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. — View Citation

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. — View Citation

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;28:131. doi: 10.1186/1756-9966-28-131. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	Quality of life was evaluated according to MDASI-K		the overall assessment period (0 to 72 hours)	Yes