Recurrent Rectal Cancer Clinical Trial
Official title:
A Phase II Study of Panitumumab in Combination With FOLFIRI After Progression on FOLFIRI Plus Bevacizumab in KRAS(Kirsten Rat Sarcoma) and NRAS Wild-Type Metastatic Colorectal Cancer.
This phase II trial studies how well panitumumab and combination chemotherapy works in treating patients with metastatic colorectal cancer previously treated with combination chemotherapy and bevacizumab. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving panitumumab and combination chemotherapy together may kill more tumor cells
PRIMARY OBJECTIVES:
I. To determine the median progression-free survival in patients treated with leucovorin
calcium, fluorouracil, and irinotecan hydrochloride (FOLFIRI) and panitumumab for K-ras and
NRAS wild-type, metastatic colorectal carcinoma who have already progressed on FOLFIRI +
Bevacizumab.
SECONDARY OBJECTIVES:
I. To determine the frequency and severity of toxicities of the regimens. II. To determine
overall response rate. III. To determine the median overall survival and the overall survival
rate at 1 year.
OUTLINE:
Patients receive panitumumab intravenously (IV) over 60-90 minutes, leucovorin calcium IV
over 90 minutes, fluorouracil IV continuously over 46 hours, and irinotecan hydrochloride IV
over 90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
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