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
OBJECTIVES:
Primary
- 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
colorectal cancer.
Secondary
- 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
day 1.
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.
Interventional
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
No
Joseph Bubalo, PharmD, BCPS, BCOP
Study Chair
OHSU Knight Cancer Institute
United States: Federal Government
CDR0000503649
NCT00381862
June 2006
July 2008
Name | Location |
---|---|
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 |