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

Phase 2

Terminated

• Conditions: Nausea; Vomiting; Terminally Ill
• Interventions: Drug: Palonosetron

• Registration Number: NCT00982995
• Lead Sponsor: University of Michigan Rogel Cancer Center

Brief Summary

The primary objective of this study is to determine the complete response (no vomiting and no need for other medications to treat nausea) in terminally ill patients suffering from nausea and/or vomiting, who are treated with palonosetron. Another objective is to determine the partial response (relief of nausea and vomiting to the extent that the patient wishes to continue treatment with palonosetron) after being treated with palonosetron. Palonosetron is currently approved by the FDA to prevent nausea and vomiting associated with chemotherapy. The investigators are testing this medication to see if it can help to relieve nausea and vomiting not associated with chemotherapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-21
• Study First Submitted QC: 2009-09-22
• Study First Posted: 2009-09-23
• Study Start: 2010-11
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Results First Submitted: 2014-09-05
• Results First Submitted QC: 2014-09-05
• Results First Posted: 2014-09-15
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-05
• Last Update Posted: 2015-12-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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 palonosetron.
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 study.
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Palonosetron	Palonosetron	Palonosetron 0.25 mg I.V. bolus

Primary Outcome Measures

Name	Time	Method
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.	96 hours after dosing

Secondary Outcome Measures

Name	Time	Method
To Determine the Partial Response (Relief of Nausea and Vomiting to the Extent That the Patient Desires Continued Dosing With Palonosetron,) in Terminally Ill Patients Suffering From Nausea and/or Vomiting, Treated With Palonosetron	96 hours after dosing

Trial Locations

Locations (1)

University of Michigan Comprehensive Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States