A Study of Perioperative Chemotherapy Plus Panitumumab in Patients With Colorectal Cancer Liver Metastases
Status:
Completed
Trial end date:
2013-06-01
Target enrollment:
Participant gender:
Summary
This is a phase II study to assess whether treatment with chemotherapy drugs FOLFOX
(5-Fluorouracil (5FU), Oxaliplatin (Eloxatin) and Leucovorin (Folinic Acid)) or FOLFIRI
(5-Fluorouracil (5FU), Irinotecan (Camptosar) and Leucovorin (Folinic Acid))and panitumumab
before and after surgery can improve outcome in patients with liver metastases (the cancer
has spread to other parts of the body such as the liver) that are resectable (can be
surgically removed), from colorectal cancer that have a non mutant (wild-type) K-ras gene.
FOLFOX/FOLFIRI is an intravenous (given by vein) chemotherapy combination that is approved
for colorectal cancer while panitumumab is also an intravenous drug and have been approved
for treatment of refractory (not responding treatment) metastatic colorectal cancer whose
cancers have the K-ras gene. These drugs are not approved for the treatment of colorectal
cancer liver metastases (CRCLM) who can have surgery.
Patients will receive FOLFOX/FOLFIRI and panitumumab for four 2-week cycles before surgery.
Surgery will be done no sooner than 4 weeks and no later than 8 weeks, after completion of
the fourth cycle of chemotherapy.
If the liver metastases after the chemotherapy and surgery decreases or stops growing, then
chemotherapy will be given after surgery. Treatments will start no sooner than 4 weeks, and
no later than 12 weeks, after surgery. Patients will receive a maximum of 8 cycles of
treatment with the combination of drugs and then receive panitumumab alone for a maximum of
12 cycles.
On treatment visits, patients will also have tests and procedures done. As part of the study,
patients will provide archival tumor tissue and sample of tissue removed from surgery for
K-ras testing. Patients will also be given the option of allowing the collected tissue for
research (biomarker) studies and banking for future studies.