NCT00226941 - A Phase 1-2 Trial of Cetuximab in Combination With Oxaliplatin, Capecitabine, and Radiation Therapy Followed by Surgery for Locally-advanced Rectal Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

June 30, 2004

Primary Completion Date

March 31, 2008

Study Completion Date

February 28, 2009

Conditions

Rectal CancerColo-rectal Cancer

Interventions

DRUG

Cetuximab

Cetuximab is a chimeric anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody, administered via a intravenous (IV) infusion at 400 mg/m² (initial loading dose) or 250 mg/m² (weekly dose). Dosage is based on m² of body surface area (BSA)

DRUG

Oxaliplatin

Oxaliplatin is a cancer medication used to treat colorectal cancer, and is administered on Days 2 and 23.

DRUG

Capecitabine

Capecitabine is a cancer medication, and is administered based on m² of body surface area (BSA) delivered in equivalent morning and evening doses

RADIATION

Radiotherapy

"Radiotherapy is administered on weekdays in 180 centigray fractions (doses), for 28 total fractions delivering a total dose of 5040 centigray (cGy)"

DRUG

Diphenhydramine hydrochloride (HCl)

Diphenhydramine HCl 50 mg (or equivalent) is administered as a per-medication for cetuximab

Trial Locations (1)

94305

Stanford University School of Medicine, Stanford