Acute Myelogenous Leukemia Clinical Trial
Official title:
Phase II, Open, Randomized Comparative Trial of Two Different Schedules of Palonosetron Versus Ondansetron for the Prevention of Nausea and Vomiting in Patients With Hematologic Malignancies Receiving Regimens Containing High-dose Cytarabine
Verified date | August 2012 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 150 |
Est. completion date | September 2009 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. 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. 2. 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. Exclusion Criteria: 1. 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. 2. Patients with ongoing emesis due to any organic etiology. 3. Patients with known hypersensitivity to the study drug or to other selective 5-HT3 receptor antagonists. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | UT MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | Eisai Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
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