Spots Global Cancer Trial Database for Short-Infusion Ziv-aflibercept in Treating Patients With Metastatic Colorectal Cancer Receiving Combination Chemotherapy
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Trial Identification
Brief Title: Short-Infusion Ziv-aflibercept in Treating Patients With Metastatic Colorectal Cancer Receiving Combination Chemotherapy
Official Title: A Prospective Study of Short Infusion of Ziv-Aflibercept in Combination With FOLFIRI in Patients With Metastatic Colorectal Cancer
Study ID: NCT01941173
Study Description
Brief Summary: 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Marwan Fakih
Affiliation: City of Hope Medical Center
Role: PRINCIPAL_INVESTIGATOR
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