22 Participants Needed

Regorafenib + Anti-EGFR Therapy for Colorectal Cancer

Recruiting at 15 trial locations
BA
Overseen ByBenjamin A. Weinberg
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Academic and Community Cancer Research United
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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

DH

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

Alanine aminotransferase (ALT) and aspartate amino-transferase (AST) =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer) (obtained =< 7 days prior to randomization)
Absolute neutrophil count (ANC) >= 1200/mm^3 (obtained =< 7 days prior to randomization)
I can swallow and keep down pills.
See 18 more

Exclusion Criteria

I have not had major surgery or a significant injury in the last 28 days.
I have or had a pheochromocytoma.
My heart condition does not severely limit my daily activities.
See 31 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive regorafenib or anti-EGFR monoclonal antibody therapy, with cycles repeating every 28 days until disease progression or unacceptable toxicity

Variable, up to 20 months
Visits every 28 days

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

3 years
Follow-up at 30 days, then every 3 months

Treatment Details

Interventions

  • Cetuximab
  • Irinotecan
  • Panitumumab
  • Regorafenib
Trial Overview The study tests regorafenib in combination with anti-EGFR therapy (cetuximab or panitumumab) versus the reverse order for metastatic colorectal cancer treatment. It aims to see which sequence works better for controlling cancer growth.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Arm B (cetuximab, panitumumab, irinotecan)Experimental Treatment3 Interventions
Patients receive cetuximab or panitumumab IV over 30-90 minutes on days 1 and 15. Patients may also receive irinotecan IV on days 1 and 15 as determined by the study doctor. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. If received as initial treatment, patients who experience disease progression may switch over to the other treatment regimen, per treating physician discretion.
Group II: Arm A (regorafenib)Experimental Treatment1 Intervention
Patients receive regorafenib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. If received as initial treatment, patients who experience disease progression may switch over to the other treatment regimen, per treating physician discretion.

Cetuximab is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Erbitux for:
  • 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
🇪🇺
Approved in European Union as Erbitux for:
  • 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

Trials
54
Recruited
4,900+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+
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