A Single Arm Phase II Trial of Panitumumab in Cetuximab Refractory KRAS Wild-Type Colorectal Cancer
- 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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the response rate of single agent panitumumab among patients with KRAS wild-type colorectal cancer previously treated with cetuximab.
Aram Hezel, MD
Massachusetts General Hospital
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|