This randomized phase II trial studies how well combination chemotherapy together with or without panitumumab works in treating patients with colorectal cancer that has spread to the liver previously treated with surgery. Drugs used in chemotherapy, such as floxuridine, irinotecan hydrochloride, fluorouracil, and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Hepatic arterial infusion (HAI) uses a catheter to carry cancer-killing substances directly into the liver. Immunotherapy with monoclonal antibodies, such as panitumumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving floxuridine via HAI and combination chemotherapy with or without panitumumab works better in treating colorectal cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01312857.
PRIMARY OBJECTIVES:
I. To determine if panitumumab with HAI in combination with systemic chemotherapy can increase 15 month recurrence free survival (RFS) for colorectal cancer patients with resected liver metastases.
SECONDARY OBJECTIVES:
I. To assess toxicity.
II. To determine survival.
III. To analyze tumor tissue for predictive biomarkers (such as neuroblastoma v-ras oncogene homolog [NRAS], B-raf proto-oncogene, serine/threonine kinase [BRAF], phosphatidylinositol-4,5-bisphosphate 3-kinase [PIK3CA], v-akt murine thymoma viral oncogene homolog 1 [AKT1] and mitogen-activated protein kinase kinase 1 [MEK1]), and correlate with patient progression and survival following therapy.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive floxuridine via HAI on day 1. Patients also receive panitumumab intravenously (IV) over 30-60 minutes, irinotecan hydrochloride IV over 30-60 minutes, leucovorin calcium IV over 30-60 minutes, and fluorouracil IV continuously over 48 hours on days 15 and 29.
ARM B: Patients receive floxuridine, irinotecan hydrochloride, leucovorin calcium, and fluorouracil as in Arm A.
In both arms, treatment repeats every 36 days for 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 4 months for 2 years, every 6 months for 1 year, and then annually thereafter.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorNancy Ellen Kemeny