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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Acute Myelogenous Leukemia, Chemotherapy-induced Nausea and Vomiting

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Trial Information

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


Chemotherapy-related nausea and vomiting is a frequent problem among patients with leukemia
that can lead to further medical problems, such as malnutrition, dehydration, electrolyte
imbalance, and a lower quality of life. Cytarabine, one of the drugs that is used to treat
AML and high-risk MDS, is known to cause nausea and/or vomiting, so all patients that
receive chemotherapy with cytarabine also need to receive medication to prevent these side
effects.

One standard-of-care drug to treat chemotherapy-related nausea and vomiting is called
Ondansetron. Palonosetron is a new drug similar to Ondansetron that is designed to stay
longer in the bloodstream. Researchers want to find out if palonosetron can prevent nausea
and vomiting better than ondansetron.

Women who are able to have children must have a negative blood or urine pregnancy test
before starting treatment.

If you are still eligible to take part in this study, you will be randomly assigned (as in
the roll of the dice) to one of 3 treatment groups. Participants in the first group will be
given Ondansetron as an intravenous (IV--through a needle in your vein) continuous infusion,
from 30 minutes before your chemotherapy treatment until 12 hours after chemotherapy ends.
This is considered the standard of care.

Participants assigned to the second treatment group will be given palonosetron once a day by
IV injection for 5 days. Each dose will be given over a period of 30 seconds, 30 minutes
before your chemotherapy treatment.

Participants assigned to the third treatment group will be given palonosetron once a day by
IV injection, on Days 1, 3, and 5 of chemotherapy treatment. Each dose will be given over a
period of 30 seconds, 30 minutes before your chemotherapy treatment.

No matter what group you are assigned to, you will receive extra medication for nausea
and/or vomiting as needed.

You will be asked to fill out a study diary daily for 7 days, and it should take you no
longer than 10 minutes to complete. The diary will be used to record the number of episodes
of nausea and/or vomiting you experience during this study, as well as to record any need
for extra medications, and to help researchers learn which of the 2 drugs helps the best to
improve participants' quality of life (such as sleep, daily activities, and your ability to
think and reason).

You will be taken off study if intolerable side effects occur.

This is an investigational study. The Food and Drug Administration (FDA) has approved
palonosetron and Ondansetron for the prevention of chemotherapy-related nausea and vomiting,
and both drugs are commercially available. Up to 150 participants will take part in this
study. All will be enrolled at UT MD Anderson Cancer Center.


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) 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Number of Patients With Complete Response

Outcome Description:

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.

Outcome Time Frame:

7 days, starting first day of chemotherapy

Safety Issue:

No

Principal Investigator

Jorge Cortes, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2005-0389

NCT ID:

NCT01031498

Start Date:

September 2005

Completion Date:

September 2009

Related Keywords:

  • Acute Myelogenous Leukemia
  • Chemotherapy-Induced Nausea and Vomiting
  • Nausea
  • Vomiting
  • CINV
  • Leukemia
  • High-risk Myelodysplastic syndrome
  • AML
  • Hematologic malignancies
  • Hematologic Disorder
  • Continuous multi-day chemotherapy
  • High-dose cytarabine
  • Palonosetron
  • Aloxi
  • Ondansetron
  • Zofran
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Nausea
  • Vomiting
  • Hematologic Neoplasms

Name

Location
UT MD Anderson Cancer Center Houston, Texas  77030