Trial Information

Prevention of Delayed Nausea A Phase III Double-Blind Placebo-Controlled Clinical Trial

OBJECTIVES:

Primary

- Compare the efficacy of palonosetron hydrochloride and dexamethasone followed by
prochlorperazine with vs without dexamethasone in preventing delayed nausea in women
with chemotherapy-naive breast cancer. (Arms I and IV)

- Determine if palonosetron hydrochloride is more effective than granisetron
hydrochloride in controlling treatment-related delayed nausea in these patients. (Arms
I and II)

- Determine if the currently recommended antiemetic guideline of aprepitant combined with
palonosetron hydrochloride and dexamethasone is the most effective antiemetic regimen
for controlling treatment-related delayed nausea in these patients. (Arms III and IV)

Secondary

- Determine if the addition of dexamethasone to prochlorperazine is more effective than
the same regimen without dexamethasone for reducing interference with functioning
caused by chemotherapy-induced nausea and vomiting in these patients. (Arms I and IV)

- Determine if palonosetron hydrochloride is more effective than granisetron
hydrochloride for reducing interference with functioning caused by chemotherapy-induced
nausea and vomiting in these patients. (Arms I and II)

- Determine if the currently recommended antiemetic guideline of aprepitant combined with
palonosetron hydrochloride and dexamethasone is the most effective antiemetic regimen
for reducing interference with functioning due to chemotherapy-induced nausea and
vomiting in these patients. (Arms III and IV)

- Correlate sleep quality, physical exercise, and fatigue with chemotherapy-induced
nausea in these patients.

OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients
are stratified according to CCOP center and gender. Patients are randomized to 1 of 4
treatment arms. Patients receive study treatment approximately 30 minutes before their
scheduled first chemotherapy treatment.

- Arm I: Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral
placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo
once daily on days 2 and 3.

- Arm II: Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral
placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo
once daily on days 2 and 3.

- Arm III: Patients receive palonosetron hydrochloride IV and dexamethasone IV once on
day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and
oral placebo twice daily on days 2 and 3.

- Arm IV: Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral
placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone
once daily on days 2 and 3.

Quality of life is assessed at baseline and on day 4. Nausea and vomiting, fatigue, sleep
quality, exercise, and the need for rescue medication (metoclopramide) are assessed on days
1-4.

PROJECTED ACCRUAL: A total of 890 patients will be accrued for this study.