Stage IV Colon Cancer Clinical Trial
Official title:
A Phase II Study of the Combination of Aflibercept (VEGF-Trap) Plus Modified FOLFOX 6 in Patients With Previously Untreated Metastatic Colorectal Cancer
This phase II trial studies how well giving aflibercept together with combination chemotherapy works in treating patients with previously untreated colon or rectal cancer that is metastatic or locally advanced and cannot be removed by surgery. Aflibercept may stop the growth of colon or rectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving aflibercept together with combination chemotherapy may kill more tumor cells
PRIMARY OBJECTIVES:
I. To evaluate the progression free survival (PFS) of patients with untreated metastatic
colorectal cancer (mCRC) receiving the combination of modified leucovorin calcium,
fluorouracil, oxaliplatin (FOLFOX6) (mFOLFOX6) and aflibercept.
SECONDARY OBJECTIVES:
I. To evaluate the objective response rate (complete response [CR] + partial response [PR])
and the disease control rate (CR + PR + stable disease [SD]), as determined by Response
Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, of patients with untreated mCRC
receiving the combination of mFOLFOX6 and aflibercept.
II. To evaluate overall survival of patients with untreated mCRC receiving the combination of
mFOLFOX6 and aflibercept.
III. To further characterize the safety and toxicity of the combination of mFOLFOX6 and
aflibercept, including 60 day all-cause mortality.
IV. To describe patients with mCRC whose disease is rendered resectable as a consequence of
therapy with the combination of mFOLFOX 6 and aflibercept.
TERTIARY OBJECTIVES:
I. To assess the use of dynamic imaging modalities including dynamic contrast
enhanced-magnetic resonance imaging (DCE-MRI) and fluorodeoxyglucose (FDG)-positron emission
tomography (PET) to evaluate changes in vascular permeability and FDG avidity and correlate
with clinical efficacy (PFS, overall survival [OS], and response by RECIST 1.1).
II. To evaluate circulating levels of vascular endothelial growth factor A (VEGFA),
phosphatidylinositol glycan anchor biosynthesis, class F (PlGF), soluble vascular endothelial
growth factor receptor 2 (VEGF-R2), chemokine (C-X-C motif) ligand 12 (CXCL12) and chemokine
(C-X-C motif) receptor 4 (CXCR4) as potential biomarkers for efficacy of aflibercept.
III. To evaluate for the presence of VEGF single nucleotide polymorphisms (SNPs) and whether
any SNP(s), when detected, may be predictive of efficacy and/or toxicity of aflibercept.
IV. To assess microvessel density/tumor blood flow, capillary permeability and vessel
normalization by tumor biopsy pre and post treatment with aflibercept.
V. To evaluate the presence of hypertension as a predictive biomarker for clinical efficacy
of aflibercept.
OUTLINE:
Patients receive aflibercept intravenously (IV) over 1 hour followed by oxaliplatin IV over 2
hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5-15 minutes and then
continuously over 46 hours on days 1 and 15. Courses repeat every 28 days in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks.
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