Irinotecan and Cetuximab for Colorectal Cancer as Second Line Therapy

PHASE2CompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

June 30, 2006

Primary Completion Date

June 30, 2011

Study Completion Date

June 30, 2011

Conditions
Colon CancerRectum Cancer
Interventions
DRUG

Cetuximab

The treatment will include cetuximab 500 mg/m² IV for 120 minutes followed by irinotecan 180 mg/m² or 60 minutes. The starting dose of irinotecan for patients who are 70 years old or greater, or who have had radiation therapy to the abdomen or pelvis, or whose level of functioning is poor (performance status of 2) will have a starting dose of 150 mg/m2 for irinotecan. All subsequent treatments will include cetuximab 500 mg/m² IV over 60 minutes and irinotecan 150 mg/m² or 180 mg/m2 intravenously over 60 minutes every 2 weeks.

DRUG

Irinotecan

The treatment will include cetuximab 500 mg/m² IV for 120 minutes followed by irinotecan 180 mg/m² or 60 minutes. The starting dose of irinotecan for patients who are 70 years old or greater, or who have had radiation therapy to the abdomen or pelvis, or whose level of functioning is poor (performance status of 2) will have a starting dose of 150 mg/m2 for irinotecan. All subsequent treatments will include cetuximab 500 mg/m² IV over 60 minutes and irinotecan 150 mg/m² or 180 mg/m2 intravenously over 60 minutes every 2 weeks.

Trial Locations (1)

15232

UPMC Cancer Centers, Pittsburgh

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

University of Pittsburgh

OTHER

NCT00336856 - Irinotecan and Cetuximab for Colorectal Cancer as Second Line Therapy | Biotech Hunter | Biotech Hunter