Phase II Trial of Neoadjuvant FOLFOX4 and Cetuximab for Localized Adenocarcinoma of Rectum

PHASE2TerminatedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

November 30, 2009

Study Completion Date

November 30, 2009

Conditions
Rectal Cancer
Interventions
DRUG

FOLFOX4

oxaliplatin (85mg/m2 on days 1 and 15 of each cycle)+ 5FU Bolus (400mg/m2 on days 1, 2, 15, and 16 of each cycle) + 5FU CI (600mg/m2 on days 1, 2, 15, and 16 of each cycle) + Leucovorin (200mg/m2 on days 1, 2, 15, and 16 of each cycle)

DRUG

Cetuximab

Cetuximab 400mg/m2 on day 1 only, 250mg/mr on days 8, 15, and 22 of each cycle.

Trial Locations (1)

53792

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison

Sponsors
All Listed Sponsors
collaborator

Sanofi

INDUSTRY

collaborator

Bristol-Myers Squibb

INDUSTRY

collaborator

Eli Lilly and Company

INDUSTRY

lead

University of Wisconsin, Madison

OTHER