Phase I/II Study of Capecitabine Plus Aflibercept to Treat Metastatic Colorectal Cancer

Summary

The Primary Phase I objectives are to determine the recommended phase II dose for the capecitabine and aflibercept doublet combination; and to describe any dose limiting and non-dose limiting toxicities. The Phase II Primary objective is to determine progression free survival associated with this regimen. The Phase II secondary objectives are to determine response rate associated with this regimen; to determine overall survival associated with this regimen; and to explore any correlation of clinical outcome with baseline and on treatment changes in blood-based angiogenesis biomarkers. This open-label, non-randomized phase I/II trial is designed to assess the safety, tolerability and RPTD of capecitabine plus aflibercept in adult subjects with metastatic colorectal cancer.

Timeline

Start

2012-08

Primary completion

2016-06-12

Completion

2016-06-12

Outcome

Met primary endpoint

paper PFS at 2 months in patients with chemotherapy refractory metastatic CRC was significantly greater than that in historical controls PMID 31675952 ↗

Publications

• Strickler JH, Rushing CN, Niedzwiecki D, McLeod A, Altomare I, Uronis HE, Hsu SD, Zafar SY, Morse MA, Chang DZ, Wells JL, Blackwell KL, Marcom PK, Arrowood C, Bolch E, Haley S, Rangwala FA, Hatch AJ, Nixon AB, Hurwitz HI. A phase Ib study of capecitabine and ziv-aflibercept followed by a phase II single-arm expansion cohort in chemotherapy refractory metastatic colorectal cancer. BMC Cancer. 2019 Nov 1;19(1):1032. doi: 10.1186/s12885-019-6234-8.

Drugs

Indications