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UMCC 2008.048 Palonosetron for the Treatment of Nausea and Vomiting in Terminally Ill Patients

Phase 2
18 Years
Not Enrolling
Nausea, Vomiting, Terminally Ill

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Trial Information

UMCC 2008.048 Palonosetron for the Treatment of Nausea and Vomiting in Terminally Ill Patients

Inclusion Criteria:

1. Patient must be at least 18 years old.

2. Patient must have a terminal diagnosis, with estimated survival of 6 months or less.

3. Patients must have nausea and/or vomiting, not relieved with 1 or more anti-nausea
medications. If the patient is treated with an anti-nausea medication, a minimum of
2 hours should pass to ensure that the medication is given a chance to be effective.
If there is no relief after 2 hours, then the patient may be treated with

4. Patient's medications must be reviewed. Any medications possibly causing nausea
should be stopped if possible. For example, if an opiate is suspected of causing
nausea, another opiate should be substituted. However, if this is not effective, or
if a medication change cannot be made, then the patient would be eligible for this

5. Patient must be able to understand and sign informed consent

6. Patients who have a bowel obstruction that will not be relieved by surgery may be
enrolled. This includes patients whose obstruction is technically unresectable, or
who are medically too ill to endure a surgery, or who refuse surgical intervention
for any reason

Exclusion Criteria:

1. Patient has received chemotherapy in the past 28 days.

2. Assessment of possible causes of the nausea and vomiting should be done and recorded.
If a reversible cause of the nausea is identified, that cause should be treated if
possible. If the treatment relieves the nausea, then the patient is excluded from
this study. Possible reversible causes of nausea and vomiting that should be
excluded are:

- Other medical conditions such as benign positional vertigo, etc.

Type of Study:


Study Design:

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

Outcome Measure:

To determine the complete response (no vomiting and no need for nausea rescue medication) in terminally ill patients suffering from nausea and/or vomiting, treated with palonosetron.

Outcome Time Frame:

96 hours after dosing

Safety Issue:


Principal Investigator

Susan Urba, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center


United States: Institutional Review Board

Study ID:

UMCC 2008.048



Start Date:

November 2010

Completion Date:

May 2013

Related Keywords:

  • Nausea
  • Vomiting
  • Terminally Ill
  • Nausea
  • Vomiting



University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752