At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single Arm Phase II Trial of Panitumumab in Cetuximab Refractory KRAS Wild-Type Colorectal Cancer
In Brief
A Phase 2 clinical trial evaluating panitumumab for Colorectal Cancer. Completed, enrolled 20 participants across 3 sites.
Detailed Summary
The purpose of this research study is to learn whether panitumumab helps treat colorectal cancer in participants who have not responded to treatment with cetuximab. Panitumumab is a human monoclonal antibody. Antibodies are proteins that recognize a foreign substance in the body and then attach themselves to it making it exposed to destruction. Panitumumab attaches itself to a protein on cancer cells called "epidermal growth factor receptor" or EGFR. EGFR helps cancer cells to grow, and blocking EGFR helps prevent cancer cells from growing.
Study Details
Timeline
Interventions
Panitumumab is administered intravenously (IV) by an infusion pump through a peripheral line or indwelling catheter using a 0.2 or 0.22-micron in-line filter infusion set-up over 1 hour 15 minutes. The starting panitumumab dose is 6 mg/kg administered every 14 days for as long as patients are on study without evidence of disease progression or demonstrating intolerance to treatment. The total dose may be rounded up or down by no greater than 10 mg. The panitumumab dose will be calculated based on the subject's actual body weight at each visit. Panitumumab will be diluted in a minimum of 100 mL of pyrogen-free 0.9% sodium chloride solution (normal saline solution, supplied by the site). The maximum concentration of the diluted solution to be infused should not exceed 10 mg/mL.