Recurrent Rectal Cancer Clinical Trial
Official title:
A Prospective Study of Short Infusion of Ziv-Aflibercept in Combination With FOLFIRI in Patients With Metastatic Colorectal Cancer
This pilot clinical trial studies short-infusion ziv-aflibercept in treating patients with metastatic colorectal cancer receiving combination chemotherapy. Ziv-aflibercept may stop the growth of colorectal cancer by blocking blood flow to the tumor. Giving the drug over a shorter infusion time may result in improved efficiency and patient satisfaction.
PRIMARY OBJECTIVES:
I. To determine the feasibility of a shorter infusion of 30 minutes and 15 minutes of
standard dose ziv-aflibercept when combined with FOLFIRI (folinic acid [leucovorin calcium],
fluorouracil, and irinotecan [irinotecan hydrochloride]) in patients with metastatic
colorectal cancer.
SECONDARY OBJECTIVES:
I. Describe the institutional safety experience with this combination using Common
Terminology Criteria for Adverse Events (CTCAE) version 4 for toxicity grading.
OUTLINE:
Patients receive ziv-aflibercept intravenously (IV) over 15-30 minutes followed by FOLFIFRI
chemotherapy comprising leucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over
90 minutes, and fluorouracil IV over 46 hours on day 1. Courses repeat every 2 weeks in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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