Palonosetron for the Treatment of Nausea and Vomiting in Terminally Ill Patients (HUM21469)

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

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.

Study Overview

• Status: Terminated
• Conditions: Nausea; Vomiting; Terminally Ill
• Intervention / Treatment: Drug: Palonosetron

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Palonosetron; Palonosetron 0.25 mg I.V. bolus

Drug: Palonosetron; Palonosetron 0.25 mg as an I.V. bolus. After Palonosetron treatment, no other nausea medication will be given for 2 hours. At that point, if no relief from nausea or vomiting has occured then other anti-nausea medications may be prescribed, and patient will be taken off study. If relief from nausea and vomiting as a result of the Palonosetron occurs, patient will not receive any more anti-nausea medication unless nausea recurs. If it does recur and patient wishes to be retreated with Palonosetron. This may be repeated for a total of 3 doses, as long as it is providing relief.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: September 21, 2009
• First Submitted That Met QC Criteria: September 22, 2009
• First Posted (Estimate): September 23, 2009

Study Record Updates

• Last Update Posted (Estimate): December 4, 2015
• Last Update Submitted That Met QC Criteria: November 5, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Serotonin Agents; Serotonin Antagonists; Serotonin 5-HT3 Receptor Antagonists; Palonosetron
• Other Study ID Numbers: UMCC 2008.048