Phase II study to determine surgical conversion rate in patients receiving neoadjuvant mFOLFOX7 plus cetuximab for unresectable wild-type KRAS colorectal cancer with metastases confined to liver.
Authors: S. A. Jacobs, C. J. Allegra, L. D. Wagman, D. A. Geller, M. J. O'Connell, M. E. Buyse, N. Wolmark
Journal: Journal of Clinical Oncology (2010)

Article Tools Trials in Progress Poster Session Article Tools OPTIONS & TOOLS Export Citation Track Citation Add To Favorites Rights & Permissions COMPANION ARTICLES No companion articles ARTICLE CITATION DOI: 10.1200/jco.2010.28.15_suppl.tps190 Journal of Clinical Oncology - published online before print May 20, 2010 Phase II study to determine surgical conversion rate in patients receiving neoadjuvant mFOLFOX7 plus cetuximab for unresectable wild-type KRAS colorectal cancer with metastases confined to liver. S. A. JacobsxS. A. JacobsSearch for articles by this author , C. J. AllegraxC. J. AllegraSearch for articles by this author , L. D. WagmanxL. D. WagmanSearch for articles by this author , D. A. GellerxD. A. GellerSearch for articles by this author , M. J. O'ConnellxM. J. O'ConnellSearch for articles by this author , M. E. BuysexM. E. BuyseSearch for articles by this author , N. WolmarkxN. WolmarkSearch for articles by this author Show More University of Pittsburgh Cancer Institute, Pittsburgh, PA; University of Florida, Gainesville, FL; Center for Cancer Prevention and Treatment, St. Joseph's Hospital of Orange, Orange, CA; University of Pittsburgh Liver Cancer Center, Pittsburgh, PA; National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA; IDDI, Louvain-la-Neuve, Belgium; National Surgical Adjuvant Breast and Bowel Project and Allegheny General Hospital, Pittsburgh, PA https://doi.org/10.1200/jco.2010.28.15_suppl.tps190 Abstract Abstract TPS190 Background: Resection of colorectal cancer hepatic metastases can provide long-term survival for 20-40% of patients (pts) without extrahepatic disease who undergo complete ("curative") surgical resection of liver tumors. Cytotoxic chemotherapy given to patients with liver-only metastatic colorectal cancer has been shown to convert some pts whose liver tumors were considered unresectable to resectable with improvement in long-term survival for pts undergoing potentially curative resection (Pozzo et al. Ann Oncol 15:933.2004). KRAS status has been shown to predict for benefit from EGFR inhibitors. Escalation of cetuximab (EVEREST trial) demonstrated that tumor response rates can be enhanced from 13% to 30% with escalation of cetuximab dose (Tejpar et al JCO 25(18s) abst 4037, 2007). The primary goal of neoadjuvant chemotherapy with targeted therapy for unresectable, liver-only metastatic colorectal cancer is to produce enough tumor shrinkage to allow a curative metastasectomy. A secondary goal of chemotherapy is to destroy systemic or hepatic micrometastases. Methods: This NSABP Foundation Research Program study (FC-6) is designed as a phase II, two-stage, multicenter clinical trial for patients with unresectable, wild-type KRAS, colorectal cancer with metastases confined to liver. Sixty pts from approximately 20 centers with expertise in liver resection will be enrolled. Enrollment will begin Spring 2010. All pts will receive treatment every 2 weeks during each 8-week cycle for a maximum of 3 cycles. Starting doses are: oxaliplatin 85 mg/m2 IV; leucovorin 400 mg/m2 IV; 5-FU 3,000 mg/m2 IV continuous infusion over 46 hours; and cetuximab 500 mg/m2 IV (cetuximab dose will be escalated by 100 mg/m2 every 2 weeks to maximum dose of 800 mg/m2). The primary endpoint is to determine the percentage of pts who had a potentially curative liver metastasectomy as defined as completely resected and/or ablated malignant disease (R0 resection). The ultimate goal is to improve the possibility of cure for pts with unresectable metastatic colorectal cancer confined to the liver by increasing the surgical conversion rate. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration IDDI Roche, sanofi-aventis IDDI ImClone Systems © 2010 by American Society of Clinical Oncology