BrUOG C261:Single Agent Adjuvant Aflibercept for Patients With Resected or Ablated Metastatic Colorectal Cancer: A Randomized Phase II Study
There are over 1.2 million new cases of colorectal cancer and 600,000 deaths worldwide. The
liver is the dominant site of metastases. Approximately 20-25% of patients with advanced
colorectal cancer will be candidates for resection/ablation of all sites of metastatic
disease.1 Unfortunately, despite resection/ablation of all metastatic sites only about 20%
of these patients are ultimately cured.1 An effective adjuvant agent would prevent tumor
recurrence.
Aflibercept and bevacizumab are effective when combined with FOLFIRI for metastatic colon
cancer. Neither has been tested in a randomized study in the adjuvant setting for patients
with resected metastatic disease. Since aflibercept more effectively inhibits all forms of
VEGF including VEGF-A, VEGF-B and PIGF, in striking contrast to bevacizumab which inhibits
only VEGF-A, aflibercept likely will be more effective than bevacizumab as a single agent in
the adjuvant metastatic setting. Therefore, we propose a randomized study of adjuvant
aflibercept for patients metastatic colorectal cancer who have received 10-12 cycles of
perioperative FOLFOX and have had had a complete response to all sites of metastases after
chemotherapy and local modalities such as surgical resection or ablation. SBRT may also be
used to produce a complete response in a metastatic site not easily amenable to surgery or
ablation. Only patients with very high risk of recurrence, defined as 3 or more metastatic
sites, will be included in this study.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease free survival in patients with advanced colorectal cancer who have undergone resection/ablation of all metastatic sites.
Every 3 months until disease progression with no estimated time period
No
Howard Safran, MD
Principal Investigator
Brown University Oncology Research Group
United States: Food and Drug Administration
BrUOG C261
NCT01669720
December 2012
January 2016
Name | Location |
---|---|
Rhode Island Hospital | Providence, Rhode Island 02903 |
Virginia Mason Medical Center | Seattle, Washington 98111 |
Thomas Jefferson University Hospital | Philadelphia, Pennsylvania 19131 |
The Miriam Hospital | Providence, Rhode Island 02903 |
Wake Forest Medical Center | Winston-Salem, North Carolina 27157 |
Stanford Hospital and Clinic | Palo Alto, California 94305 |
University of Vermont Medical Center | Burlington, Vermont 05401 |