Phase II Trial of Aprepitant & Palonosetron for CINV Prevention w FOLFOX

PHASE2CompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

June 30, 2006

Primary Completion Date

March 31, 2008

Study Completion Date

July 31, 2008

Conditions
Colorectal CancerNausea and Vomiting
Interventions
DRUG

aprepitant

Aprepitant 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle

DRUG

dexamethasone

Dexamethasone 12 mg PO on 1st day of study drug and 8 mg PO on days 2-4

DRUG

fluorouracil

as per institutional standard of care

DRUG

irinotecan hydrochloride

as per institutional standard of care

DRUG

leucovorin calcium

as per institutional standard of care

DRUG

oxaliplatin

as per institutional standard of care

DRUG

palonosetron hydrochloride

Palonosetron 0.25 mg IV push on day 1 only.

PROCEDURE

quality-of-life assessment

baseline

Trial Locations (6)

31405

St. Josephs/Cander Hospital, Savannah

60426

Ingalls Memorial Hospital, Harvey

64104

Kansas City Cancer Center, Kansas City

76508

Texas A & M university / Scott and White Clinic, Temple

86720

Kaiser Permanente, Hilo

97239-3098

OHSU Knight Cancer Institute, Portland

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

OHSU Knight Cancer Institute

OTHER

NCT00381862 - Phase II Trial of Aprepitant & Palonosetron for CINV Prevention w FOLFOX | Biotech Hunter | Biotech Hunter