Comparative Study of Cetuximab and Radiation Vs Surgery Before or After Radiation in Patients With Colorectal Carcinoma

PHASE2WithdrawnINTERVENTIONAL
Enrollment

450

Participants

Timeline

Start Date

February 28, 2010

Primary Completion Date

February 28, 2014

Study Completion Date

February 28, 2014

Conditions
Colorectal Carcinoma
Interventions
OTHER

Cetuximab and Radiation Therapy

Patients will receive Cetuximab and Radiation Therapy. Patients will receive a dose of Cetuximab through Intravenous (IV). The initial dose is 400 mg/m2 administered as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min) and weekly dose is 250 mg/m2 infused over 60 minutes (maximum infusion rate 10 mg/min) until disease progression or unacceptable toxicity. Radiation treatment for Colorectal Cancer are Intensity Modulated Radiation Therapy (IMRT). IMRT delivers radiation directly to the tumor and modulates the intensity of the radiation with laser accuracy.

PROCEDURE

Surgery and Radiation Therapy

Patients will undergo Surgery before or after Radiation Therapy. Colorectal Cancer Surgery are Colon resection (Colectomy), Rectum resection (Proctectomy), Colostomy, and Radiofrequency ablation. Radiation treatment for Colorectal Cancer are Intensity Modulated Radiation Therapy (IMRT). IMRT delivers radiation directly to the tumor and modulates the intensity of the radiation with laser accuracy.

Trial Locations (1)

07726

Practicing Physician in New Jersey, Englishtown

Sponsors
All Listed Sponsors
collaborator

Eli Lilly and Company

INDUSTRY

collaborator

Bristol-Myers Squibb

INDUSTRY

lead

American Scitech International

OTHER