A Study With Neoadjuvant mFOLFOX7 Plus Cetuximab to Determine the Surgical Conversion Rate for Unresectable Colorectal Cancer With Metastases Confined to the Liver
Completed · Phase 2
Conditions studied: Metastatic Colorectal Cancer
In brief
FC-6 is a Phase II, multi-center clinical trial for patients with unresectable, wild-type K-RAS, colorectal cancer with metastases confined to the liver. Liver metastases must be determined by FC-6 criteria to be unresectable, and the colorectal cancer (CRC) tumor (primary or metastatic) must be found to be wild-type K-RAS. Patients with mutant K-RAS tumors are ineligible. K-RAS testing can be done through the local hospital or a tumor sample can be submitted to the FC-6 central lab (Esoterix Clinical Trial Services). A primary aim of this study is to evaluate the surgical conversion rate using cytotoxic combination chemotherapy and biologic therapy with cetuximab, a monoclonal antibody targeted against the epidermal growth factor receptor. A second primary aim is to evaluate the safety and tolerability of a chemotherapy/targeted therapy regimen in this patient population. Secondary aims include determination of clinical response rate, recurrence-free survival for patients undergoing complete resection and/or ablation of liver metastases, and overall survival.
Key facts
- Study ID
- NCT00803647
- Run by
- NSABP Foundation Inc
- People needed
- 20
- Starts
- 2010-01-01
- Expected to finish
- 2014-11-01
- Last updated by the study team
- 2021-10-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Loma Linda University Medical Center — Loma Linda, California, United States
- St. Joseph Hospital — Orange, California, United States
- Kaiser Permanente-San Diego — San Diego, California, United States
- Kaiser Permanente Medical Center - Vallejo — Vallejo, California, United States
- CCOP - Christiana Care Health Services — Newark, Delaware, United States
- M.D. Anderson Cancer Center - Orlando — Orlando, Florida, United States
- CCOP - NorthShore University HealthSystem — Evanston, Illinois, United States
- Edward Hospital — Naperville, Illinois, United States
- University of Iowa — Iowa City, Iowa, United States
- NortonHealthcare, Inc. — Louisville, Kentucky, United States
- Franklin Square Hospital Center — Baltimore, Maryland, United States
- Henry Ford Health System — Detroit, Michigan, United States
- CCOP - Grand Rapids Clinical Oncology Program — Grand Rapids, Michigan, United States
- CCOP, William Beaumont Hospital — Royal Oak, Michigan, United States
- CCOP - Metro-Minnesota — Saint Louis Park, Minnesota, United States
- CCOP, Dayton, OH — Dayton, Ohio, United States
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
- Allegheny Cancer Center at Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
- NSABP Foundation, Inc. — Pittsburgh, Pennsylvania, United States
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States
- CCOP - Upstate Carolina — Spartanburg, South Carolina, United States
- Vermont Cancer Center at University of Vermont — Burlington, Vermont, United States
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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