Panitumumab in Cetuximab Refractory KRAS Wild-Type Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title: A Single Arm Phase II Trial of Panitumumab in Cetuximab Refractory KRAS Wild-Type Colorectal Cancer

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

• Panitumumab will be given to the participants through a central line. A central line is a long, thin tube (catheter) that is inserted through the skin into a large vein in the chest. This is placed by a radiologist or surgeon.

• Panitumumab will be given in 4-week cycles. Panitumumab infusions will be given on days 1 and 15 of each cycle (every 2 weeks).

• The following procedures will be performed on days 1 and 15 of each cycle, before each infusion: physical exam; questions about any symptoms or side effects; performance status; routine blood tests and CT or MRI (every 2 cycles).

• Participants can continue to receive panitumumab until their disease gets worse or they experience unacceptable side effects. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

• NCT number: NCT00842257
• Study type: Interventional
• Source: Massachusetts General Hospital
• Contact: Aram Hezel, MD
• Phone: 617-643-3813
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 2010
• Completion date: March 2011