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Monoclonal Antibodies
Regorafenib + Anti-EGFR Therapy for Colorectal Cancer
Phase 2
Waitlist Available
Led By Daniel H Ahn
Research Sponsored by Academic and Community Cancer Research United
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to swallow and retain oral medication
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing how well regorafenib and anti-EGFR therapy (cetuximab or panitumumab) works for the treatment of patients with colorectal cancer.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include fatigue, diarrhea, hand-foot skin reactions from regorafenib; skin rash and allergic reactions from cetuximab/panitumumab; and typical chemotherapy-related issues like nausea and low blood counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can swallow and keep down pills.
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I am able to care for myself and perform daily activities.
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My cancer does not have the BRAF v600E mutation.
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My condition worsened or I couldn't tolerate treatments like fluoropyrimidine, oxaliplatin, or irinotecan.
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My colorectal cancer cannot be removed by surgery and has spread.
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My cancer does not have mutations in the KRAS or NRAS genes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival (OS)
Secondary outcome measures
First progression-free survival (PFS)
Incidence of adverse events
Objective response rate
+3 moreTrial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan
2017
Completed Phase 4
~2680
Panitumumab
2020
Completed Phase 3
~6490
Cetuximab
2011
Completed Phase 3
~2480
Regorafenib
2014
Completed Phase 2
~1580
Find a Location
Who is running the clinical trial?
Academic and Community Cancer Research UnitedLead Sponsor
53 Previous Clinical Trials
5,114 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,645 Total Patients Enrolled
Daniel H AhnPrincipal InvestigatorAcademic and Community Cancer Research United
1 Previous Clinical Trials
36 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I haven't had significant bleeding or a bleeding disorder in the last 4 weeks.I am of childbearing age and do not plan to use birth control.My cancer is MSI-H and I haven't had PD-1 antibody therapy.I have brain or meningeal tumors but have been stable for over 6 months after treatment.I have had an organ transplant.I can swallow and keep down pills.I take medication for seizures.I understand the study drug may affect my DNA and could harm a pregnancy.You are willing to give samples of your tissue and blood for research purposes.I have HIV or active hepatitis B/C needing antiviral treatment.I am able to care for myself and perform daily activities.I have a history of chronic hepatitis B or C.I am currently breastfeeding.My cancer does not have the BRAF v600E mutation.My condition worsened or I couldn't tolerate treatments like fluoropyrimidine, oxaliplatin, or irinotecan.I agree to share my samples and data from this trial for future research.You are allergic or have had bad reactions to any of the study drugs or ingredients in them.My colorectal cancer cannot be removed by surgery and has spread.You have a history of drug or alcohol abuse, or any medical, psychological, or social conditions that may make it difficult for you to take part in the study or for the researchers to accurately evaluate the study results.My cancer does not have mutations in the KRAS or NRAS genes.I do not have a serious ongoing infection.I am on medication for irregular heartbeats.I haven't had any cancer treatments in the last 3 weeks.I have a wound, ulcer, or bone fracture that hasn't healed.I am not on any experimental drugs for my cancer.I have a condition that affects how my body absorbs nutrients.I have had a different type of cancer than colorectal within the last 3 years.I have been treated with regorafenib, cetuximab, or panitumumab.I haven't had a stroke, clot in my leg, or lung clot in the last 6 months.I currently have symptoms of interstitial lung disease.I don't have severe side effects from previous treatments, except for hair loss or mild nerve damage.I have fluid in my chest or abdomen causing significant breathing problems.I have had a recent heart attack or started having chest pain at rest in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (regorafenib)
- Group 2: Arm B (cetuximab, panitumumab, irinotecan)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Regorafenib been cleared by the FDA?
"Regorafenib's safety was given a score of 2 by our Power team. This is due to the fact that, while Phase 2 trials give some indication of a medication's safety, they provide no clinical data supporting efficacy."
Answered by AI
How many total volunteers are being sought for this research project?
"One hundred and twenty-four eligible individuals are required for this clinical trial. Patients can choose to participate at Siouxland Regional Cancer Center in Sioux City, Iowa or University of Nebraska Medical Center in Omaha, Nebraska."
Answered by AI
How is Regorafenib most often employed?
"Regorafenib is an effective therapy for patients with colorectal carcinoma, ovarian cancer, and sarcoma."
Answered by AI
Are there any other publications which mention Regorafenib?
"The drug Regorafenib was first studied in the year 2000 at Wellington Hospital. However, as of right now, there have been 966 completed clinical trials. In addition, 455 live studies are being conducted with many taking place in Sioux City, Iowa."
Answered by AI
Who else is applying?
What site did they apply to?
Emory University Hospital/Winship Cancer Institute
What portion of applicants met pre-screening criteria?
Met criteria
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