Recurrent Rectal Cancer Clinical Trial
Official title:
Phase II Study of Ziv-Aflibercept Followed by the Addition of 5-FU in the Third Line Setting of Metastatic Colorectal Cancer
This phase II trial studies how long it takes colorectal cancer resistant to standard treatment to grow while receiving treatment with ziv-aflibercept, and how well adding fluorouracil and leucovorin calcium to ziv-aflibercept works in treating patients with stage IV colorectal cancer after they progress on ziv-aflibercept alone. Ziv-aflibercept may stop the growth of colorectal cancer by blocking the formation of tumor blood vessels. Fluorouracil and leucovorin calcium are drugs used in chemotherapy. Fluorouracil works to stop the growth of tumors cells by preventing the cells from growing and dividing. Leucovorin calcium helps fluorouracil work better. Adding fluorouracil and leucovorin calcium to ziv-aflibercept may be an effective treatment for patients who progress on ziv-aflibercept alone.
PRIMARY OBJECTIVES:
I. To determine the progression‐free survival during the first phase of the study (PFS1) in
patients with metastatic colorectal cancer treated with single agent ziv‐aflibercept after
progressing on leucovorin calcium, fluorouracil, oxaliplatin (FOLFOX) and leucovorin
calcium, fluorouracil, irinotecan hydrochloride (FOLFIRI) with bevacizumab +/‐ cetuximab or
panitumumab.
II. To determine the progression‐free survival (PFS2) in patients with metastatic colorectal
cancer treated with ziv‐aflibercept and 5‐fluorouracil (fluorouracil), after progressing on
ziv‐aflibercept alone.
SECONDARY OBJECTIVES:
I. Overall survival. II. Response rate. III. Incidence and nature of adverse events. IV.
Growth modulation index (ratio of PFS2/PFS1).
TERTIARY OBJECTIVES:
I. To determine relevant biomarkers which can distinguish patients with a progression free
survival greater than 3 months on single agent ziv‐aflibercept (tumor vascular endothelial
growth factor [VEGF], vascular endothelial growth factor receptor [VEGFR]1 and 2, baseline
plasma phosphatidylinositol glycan anchor biosynthesis, class F [PlGF]).
II. Plasma levels of VEGF‐A, B, C, D, intercellular adhesion molecule 1 (ICAM), chemokine
(C-X-C motif) ligand 1 (melanoma growth stimulating activity, alpha) (Gro alpha), hepatocyte
growth factor (HGF), stem cell growth factor beta (SCGF beta) prior to treatment and with
each cycle of therapy.
III. Single nucleotide polymorphisms (SNPs) of VEGFA, VEGFR1 & 2 & 3, interleukin (IL)8,
angiopoietin-2 (Ang2), IL‐6, ICAM, PlGF, neuropilin (NRP)1 & 2, chemokine (C-X-C motif)
receptor 2 (CXCR2) and others in the angiogenic pathway.
IV. Tumor messenger ribonucleic acid (mRNA) expression levels of VEGF B, C, D, VEGFR 3; NRP
1, 2, and VEGF isoforms on biopsy specimens taken at trial initiation and upon disease
progression and addition of 5‐FU.
V. Correlation of biomarkers with toxicity of ziv‐aflibercept alone and with 5‐FU.
OUTLINE:
PHASE I: Patients receive ziv‐aflibercept intravenously (IV) over 1 hour on day 1. Courses
repeat every 14 days in the absence of disease progression or unacceptable toxicity. At the
time of progression, patients proceed to Phase II.
PHASE II: Patients receive ziv‐aflibercept IV over 1 hour, leucovorin calcium IV over 1
minute, and fluorouracil IV over 46 hours on day 1. Courses repeat every 14 days in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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