Short-Infusion Ziv-aflibercept in Treating Patients With Metastatic Colorectal Cancer Receiving Combination Chemotherapy
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|ClinicalTrials.gov Identifier: NCT01941173|
Recruitment Status : Withdrawn (Lack of accrual)
First Posted : September 13, 2013
Last Update Posted : July 21, 2014
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Colon Cancer Recurrent Rectal Cancer Stage IVA Colon Cancer Stage IVA Rectal Cancer Stage IVB Colon Cancer Stage IVB Rectal Cancer||Biological: ziv-aflibercept Drug: leucovorin calcium Drug: irinotecan hydrochloride Drug: fluorouracil||Not Applicable|
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.
I. Describe the institutional safety experience with this combination using Common Terminology Criteria for Adverse Events (CTCAE) version 4 for toxicity grading.
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 (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Study of Short Infusion of Ziv-Aflibercept in Combination With FOLFIRI in Patients With Metastatic Colorectal Cancer|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||July 2014|
Experimental: Treatment (ziv-aflibercept, FOLFIRI)
Patients receive ziv-aflibercept 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.
Drug: leucovorin calcium
Drug: irinotecan hydrochloride
- 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 [ Time Frame: Up to 30 days after last study treatment ]All hypersensitivity grades will be collected (including grade 1). Upon completion of the study, toxicity will be summarized and tabulated.
- Incidence of grade 3 and above toxicities, graded according to CTCAE version 4.0 [ Time Frame: Up to 30 days after last study treatment ]Upon completion of the study, toxicity will be summarized and tabulated.
- Time on protocol therapy [ Time Frame: Up to 30 days after last study treatment ]Summarized using range, median, and quartiles of time and total courses.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941173
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010|
|City of Hope Antelope Valley|
|Lancaster, California, United States, 93534|
|City of Hope- South Pasadena Cancer Center|
|South Pasadena, California, United States, 91030|
|Principal Investigator:||Marwan Fakih||City of Hope Medical Center|