Regorafenib + Anti-EGFR Therapy for Colorectal Cancer
Trial Summary
What is the purpose of this trial?
This phase II trial how well regorafenib and anti-EGFR therapy (cetuximab or panitumumab) works for the treatment of patients with colorectal cancer that cannot be removed by surgery (unresectable), has spread to nearby tissue or lymph nodes (locally advanced), or has spread to other places in the body (metastatic). Regorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab or panitumumab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The purpose of this research study is to compare the effects, good and/or bad, of taking regorafenib follow by cetuximab or panitumumab, to those that receive cetuximab or panitumumab before regorafenib.
Research Team
Daniel H Ahn
Principal Investigator
Academic and Community Cancer Research United
Eligibility Criteria
This trial is for adults with advanced colorectal cancer that can't be removed by surgery, has spread, and hasn't responded to certain treatments. Participants must have a life expectancy of at least 3 months, adequate organ function, no severe concurrent diseases or recent significant cardiovascular events. Pregnant or breastfeeding women are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive regorafenib or anti-EGFR monoclonal antibody therapy, with cycles repeating every 28 days until disease progression or unacceptable toxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
Treatment Details
Interventions
- Cetuximab
- Irinotecan
- Panitumumab
- Regorafenib
Cetuximab is already approved in United States, European Union for the following indications:
- Locally or regionally advanced squamous cell carcinoma of the head and neck
- Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck
- K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer
- BRAF V600E mutation-positive metastatic colorectal cancer
- Squamous cell carcinoma of the head and neck
- K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Academic and Community Cancer Research United
Lead Sponsor
National Cancer Institute (NCI)
Collaborator