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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

Must not have

Major surgical procedure, open biopsy, or significant traumatic injury =< 28 days prior to randomization

History of or current pheochromocytoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 20 months

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had major surgery or a significant injury in the last 28 days.

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I have or had a pheochromocytoma.

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My heart condition does not severely limit my daily activities.

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I haven't had significant bleeding or a bleeding disorder in the last 4 weeks.

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I am of childbearing age and do not plan to use birth control.

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My cancer is MSI-H and I haven't had PD-1 antibody therapy.

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I have had an organ transplant.

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I take medication for seizures.

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I understand the study drug may affect my DNA and could harm a pregnancy.

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I have HIV or active hepatitis B/C needing antiviral treatment.

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I have a history of chronic hepatitis B or C.

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I am currently breastfeeding.

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I do not have a serious ongoing infection.

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I am on medication for irregular heartbeats.

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I have a wound, ulcer, or bone fracture that hasn't healed.

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I am not on any experimental drugs for my cancer.

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I have a condition that affects how my body absorbs nutrients.

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I have had a different type of cancer than colorectal within the last 3 years.

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I have been treated with regorafenib, cetuximab, or panitumumab.

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I currently have symptoms of interstitial lung disease.

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I have fluid in my chest or abdomen causing significant breathing problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 20 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~20 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (OS)

Secondary study objectives

First Progression-free Survival (PFS)

Number of Patients Experiencing Adverse Events

Objective Response Rate

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

Cetuximab

2011

Completed Phase 3

~2480

Irinotecan

2017

Completed Phase 3

~2590