NCT00291486 - Capecitabine and 131I-huA33 in Patients With Metastatic Colorectal Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

October 31, 2003

Primary Completion Date

January 3, 2008

Study Completion Date

August 29, 2012

Conditions

Colorectal Neoplasms

Interventions

DRUG

Capecitabine

Capecitabine was administered orally at doses between 1000 and 1500 mg/m2/day depending on assigned dose level for 14 days per 21-day cycle. Daily doses were rounded to the nearest 150 mg.

DRUG

131I-huA33 (131-Iodine on humanised monoclonal antibody A33)

All patients received a dose of 5 mg huA33 conjugated to 5-8 mCi 131I. The therapy dose of 131I-huA33 comprised a constant protein dose of 10 mg/m2 huA33 regardless of dose level. The 131I-huA33 therapy dose was determined by the assigned dose level (i.e. 20, 30 or 40 mCi/m2 131I).

Trial Locations (1)

3084

Ludwig Institute Oncology Unit and Tumor Targeting Program, Austin Health, Heidelberg