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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
City of Hope Medical Center
Duarte, California, United States
City of Hope Antelope Valley
Lancaster, California, United States
City of Hope- South Pasadena Cancer Center
South Pasadena, California, United States
Feasibility of a shorter infusion time, determined by rate of greater or equal to grade 2 hypersensitivity reactions as graded according to CTCAE version 4.0
All hypersensitivity grades will be collected (including grade 1). Upon completion of the study, toxicity will be summarized and tabulated.
Time frame: Up to 30 days after last study treatment
Incidence of grade 3 and above toxicities, graded according to CTCAE version 4.0
Upon completion of the study, toxicity will be summarized and tabulated.
Time frame: Up to 30 days after last study treatment
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Given IV