Evaluation of Two Different Schedules of Palonosetron for the Prevention of Nausea and Vomiting in Patients With Metastatic Melanoma Receiving Concurrent Biochemotherapy
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
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
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 and/or 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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Cumulative Participants Response to Palonosetron
Participants response measured as incidences biochemotherapy emesis and those of nausea interfering with appetite, sleep, physical activity, social life and enjoyment of life are summarized. Response evaluated during 5-day administration of biochemotherapy and the 23 subsequent days after therapy ends.
Agop Y. Bedikian, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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