A Multi-Center, Open-Label Trial to Evaluate the Efficacy and Tolerability of Aprepitant and Palonosetron for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Colorectal Cancer (CRC) Patients Receiving FOLFOX or FOLFIRI Chemotherapy
- Evaluate the efficacy, in terms of nausea and vomiting control, of aprepitant,
palonosetron hydrochloride, and dexamethasone, in preventing chemotherapy-induced
nausea and vomiting in patients receiving FOLFOX or FOLFIRI chemotherapy for metastatic
- Assess the percentage of patients with no emesis and no rescue therapy when treated
with aprepitant, palonosetron hydrochloride, and dexamethasone during repeated courses
of FOLFOX or FOLFIRI chemotherapy.
- Assess the effects of aprepitant on nausea, appetite, taste changes (via visual
analogue scale), nutritional intake, and mucositis in these patients.
- Assess the safety of this regimen in these patients.
OUTLINE: This is an open-label, multicenter study.
Beginning 1 hour prior to the initiation of chemotherapy on day 1, patients receive oral
aprepitant on days 1-3, oral dexamethasone on days 1-4, and palonosetron hydrochloride IV on
Nausea is assessed daily for up to 4 courses of chemotherapy.
Quality of life is assessed at baseline.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Number of Participants With no Emesis and no Rescue Therapy Within 5 Days of Receiving FOLFOX and FOLFIRI in the First Cycle of Chemotherapy.
Up to 24 weeks
Joseph Bubalo, PharmD, BCPS, BCOP
OHSU Knight Cancer Institute
United States: Federal Government
|Ingalls Memorial Hospital||Harvey, Illinois 60426|
|OHSU Knight Cancer Institute||Portland, Oregon 97239|
|Kansas City Cancer Center||Kansas City, Missouri 64111|
|St. Josephs/Cander Hospital||Savannah, Georgia 31405|
|Kaiser Permanente||Hilo, Hawaii 86720|
|Texas A & M university / Scott and White Clinic||Temple, Texas 76508|