Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00412425
Status:
COMPLETED
Last Update Posted:
2012-05-04
First Post:
2006-12-14
Brief Title:
Palonosetron for Prevention of Biochemotherapy Induced Nausea and Vomiting
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Evaluation of Two Different Schedules of Palonosetron for the Prevention of Nausea and Vomiting in Patients With Metastatic Melanoma Receiving Concurrent Biochemotherapy
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objectives
Safety of palonosetron administered for control of nausea and vomiting in patients with metastatic melanoma receiving biochemotherapy
To determine the patterns and severity of nausea and vomiting in two groups of patients with metastatic melanoma receiving biochemotherapy with palonosetron premedication using two schedules of palonosetron administration
Safety of palonosetron administered for control of nausea and vomiting in patients with metastatic melanoma receiving biochemotherapy
To determine the patterns and severity of nausea and vomiting in two groups of patients with metastatic melanoma receiving biochemotherapy with palonosetron premedication using two schedules of palonosetron administration
Detailed Description:
Palonosetron is designed to work by blocking the substance serotonin from binding to the brain and gastrointestinal tract which may help to decrease nausea and vomiting
Participants in this study will be receiving biochemotherapy treatment as part of their routine care This treatment will include 3 chemotherapy drugs cisplatin vinblastine and DTIC and 2 drugs that stimulate the immune system interferon and interleukin-2 IL-2 Biochemotherapy often causes nausea vomiting loss of appetite and weight loss Palonosetron will be given on this study to try to treat the side effects of biochemotherapy
If you agree to take part in this study you will be randomly assigned as in the toss of a coin to one of 2 treatment groups You have an equal chance of being assigned to either group
Participants in Group 1 will receive palonosetron by vein over a few minutes starting 30 minutes before receiving chemotherapy on Days 1 and 4 of therapy Participants in Group 2 will receive palonosetron by vein over a few minutes on Days 1 3 and 5
All participants on this study will also receive Ativan by vein every 8 hours for 5 days Ativan is given for additional control of nausea and it will also help to sedate you In addition to palonosetron you may be given standard anti-nausea medications such as lorazepam or compazine if you experience intolerable nausea and vomiting while on study
You will also be asked to fill out a Functional Living Index-Emesis FLIE questionnaire every day for 7 days in a row The questionnaire will ask about any nausea andor vomiting you are experiencing and the effect of the therapy on your quality of life You will stay in the hospital for at least 7 days while you receive treatment
After the first course of palonosetron given with biochemotherapy your doctor will decide if you will receive additional courses of palonosetron or if you will be given another anti-nausea drug
If your doctor does decide to have you continue on palonosetron it will be given off study Your participation in this study will be over after 1 course
This is an investigational study Palonosetron has been approved by FDA for control of nausea and vomiting caused by chemotherapy However it has not been adequately evaluated for safety and effectiveness in patients receiving high dose interleukin-2 alone or in combination with chemotherapy About 30 patients will take part in this study All patients will enrolled at M D Anderson
Participants in this study will be receiving biochemotherapy treatment as part of their routine care This treatment will include 3 chemotherapy drugs cisplatin vinblastine and DTIC and 2 drugs that stimulate the immune system interferon and interleukin-2 IL-2 Biochemotherapy often causes nausea vomiting loss of appetite and weight loss Palonosetron will be given on this study to try to treat the side effects of biochemotherapy
If you agree to take part in this study you will be randomly assigned as in the toss of a coin to one of 2 treatment groups You have an equal chance of being assigned to either group
Participants in Group 1 will receive palonosetron by vein over a few minutes starting 30 minutes before receiving chemotherapy on Days 1 and 4 of therapy Participants in Group 2 will receive palonosetron by vein over a few minutes on Days 1 3 and 5
All participants on this study will also receive Ativan by vein every 8 hours for 5 days Ativan is given for additional control of nausea and it will also help to sedate you In addition to palonosetron you may be given standard anti-nausea medications such as lorazepam or compazine if you experience intolerable nausea and vomiting while on study
You will also be asked to fill out a Functional Living Index-Emesis FLIE questionnaire every day for 7 days in a row The questionnaire will ask about any nausea andor vomiting you are experiencing and the effect of the therapy on your quality of life You will stay in the hospital for at least 7 days while you receive treatment
After the first course of palonosetron given with biochemotherapy your doctor will decide if you will receive additional courses of palonosetron or if you will be given another anti-nausea drug
If your doctor does decide to have you continue on palonosetron it will be given off study Your participation in this study will be over after 1 course
This is an investigational study Palonosetron has been approved by FDA for control of nausea and vomiting caused by chemotherapy However it has not been adequately evaluated for safety and effectiveness in patients receiving high dose interleukin-2 alone or in combination with chemotherapy About 30 patients will take part in this study All patients will enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None