Palonosetron Versus Ondansetron for the Prevention of Nausea and Vomiting

NCT01031498 | Completed Phase 2 Results

• 1 other identifier: 2005-0389
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to compare the effectiveness of 3 drug schedules in preventing chemotherapy-related nausea and/or vomiting in patients with acute myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (MDS).

Conditions

Acute Myelogenous Leukemia; Chemotherapy-induced Nausea and Vomiting

Keywords

Nausea; Vomiting; CINV; Leukemia; High-risk Myelodysplastic syndrome; AML; Hematologic malignancies; Hematologic Disorder; Continuous multi-day chemotherapy; High-dose cytarabine; Palonosetron; Aloxi; Ondansetron; Zofran

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Complete Response

  Number of emesis (vomiting) episodes and no use of rescue medication during the administration of chemotherapy assessed as complete response. Complete response is defined as \< or equal to 1 episode of emesis during entire 7-day study period, no use of of rescue medication during the study period, and no more than moderate nausea (Grade 2, National Cancer Institutes (NCI) Common Terminology Criteria (CTC)) during chemotherapy.

  7 days, starting first day of chemotherapy

Study Arms (3)

Ondansetron: Standard of Care

ACTIVE COMPARATOR

Standard of care, Ondansetron 8 mg IV as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.

Drug: Ondansetron

Palonosetron Group 1 (5 Days)

EXPERIMENTAL

Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy treatment.

Drug: Palonosetron

Palonosetron Group 2 (3 Days)

EXPERIMENTAL

Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy treatment, given over 30 seconds, 30 minutes before chemotherapy treatment.

Drug: Palonosetron

Interventions

Ondansetron DRUG

8 mg IV as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.

Also known as: Zofran

Ondansetron: Standard of Care

Palonosetron DRUG

Palonosetron Group 1: 0.25 mg IV bolus over 30 seconds daily for 5 days, 30 minutes before cytarabine chemotherapy. Palonosetron Group 2: 0.25 mg IV bolus over 30 seconds on Days 1, 3, and 5 of cytarabine chemotherapy, 30 minutes before chemotherapy.

Also known as: Aloxi

Palonosetron Group 1 (5 Days); Palonosetron Group 2 (3 Days)

Eligibility Criteria

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

You may qualify if:

• Patients \> 18 years with acute myelogenous leukemia or high-risk myelodysplastic syndrome undergoing chemotherapy with high dose cytarabine (1.5 or 2gm/m\^2) containing regimens.
• Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.

You may not qualify if:

• Patients with emesis or grade 2 nausea (oral intake is significantly decreased) or 3 nausea (no significant intake requiring intravenous fluids)\</= 24 hours before chemotherapy.
• Patients with ongoing emesis due to any organic etiology.
• Patients with known hypersensitivity to the study drug or to other selective 5-HT3 receptor antagonists.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Eisai Inc.: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Vomiting; Nausea; Leukemia; Hematologic Neoplasms; Hematologic Diseases

Interventions

Ondansetron; Palonosetron

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Neoplasms by Histologic Type; Neoplasms; Hemic and Lymphatic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Isoquinolines

Results Point of Contact

• Title: Jorge Cortes, MD / Professor
• Organization: UT MD Anderson Cancer Center

eharrison@mdanderson.org

713-745-5783

Study Officials

• Jorge Cortes, MD

  UT MD Anderson Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2009
• First Posted: December 14, 2009
• Study Start: September 1, 2005
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: August 7, 2012
• Results First Posted: February 3, 2011

Record last verified: 2012-08

Locations

US (1)