Study on Regorafenib with Cetuximab or Panitumumab for Treating Advanced Colorectal Cancer
Sponsor: Academic and Community Cancer Research United
ClinicalTrials ID:NCT04117945
This clinical trial is testing the effectiveness of combining regorafenib with either cetuximab or panitumumab for patients with advanced colorectal cancer that cannot be surgically removed or has spread. The study aims to compare the outcomes of different treatment sequences to find the best approach.
Patient Parameters
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Program Overview
This study is exploring how well the drug regorafenib works when used with cetuximab or panitumumab in treating colorectal cancer that is advanced and cannot be removed by surgery. The trial will compare two treatment sequences to see which one helps patients live longer and control the cancer better. Regorafenib works by blocking certain enzymes that cancer cells need to grow, while cetuximab and panitumumab are antibodies that can stop cancer cells from growing and spreading.
Description
The main goal of this study is to compare the survival rates of patients who receive regorafenib followed by cetuximab or panitumumab, with those who receive cetuximab or panitumumab first, followed by regorafenib.
Secondary goals include comparing how long patients live without the cancer getting worse, the response of the cancer to the treatments, and the side effects experienced by patients in both treatment groups.
The study will also look at biological markers in the blood and tissue to understand how patients respond to the treatments.
Participants will be randomly assigned to one of two groups:
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Group A: Patients will take regorafenib by mouth daily for 21 days, followed by a break. If the cancer progresses, they may switch to receiving cetuximab or panitumumab through an IV, possibly with irinotecan, every 28 days.
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Group B: Patients will receive cetuximab or panitumumab through an IV, possibly with irinotecan, every 28 days. If the cancer progresses, they may switch to taking regorafenib by mouth daily for 21 days, followed by a break.
After completing the study treatment, patients will have follow-up visits 30 days later, and then every 3 months for up to 3 years.
Eligibility Criteria
Inclusion Criteria
- Have advanced colorectal cancer that cannot be surgically removed or has spread.
- Cancer must be of a specific type (KRAS, NRAS wild type and BRAF v600E wildtype).
- Have measurable cancer.
- Be in relatively good health with an ECOG performance status of 0, 1, or 2.
- Have a life expectancy of at least 3 months.
- Meet specific blood count and organ function criteria.
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
- Be willing to provide blood and tissue samples for research.
- Be able to swallow pills.
- Have previously tried certain cancer treatments without success.
- Agree to return for follow-up visits.
Exclusion Criteria
- Have previously been treated with regorafenib, cetuximab, or panitumumab.
- Have had major surgery or significant injury within 28 days before starting the study.
- Have severe heart conditions or uncontrolled high blood pressure.
- Have a history of certain blood clots or strokes within 6 months.
- Have active infections or certain viral infections.
- Have brain tumors unless stable and treated.
- Have a history of organ transplants.
- Have bleeding disorders or recent significant bleeding.
- Have other serious medical conditions that could interfere with the study.
- Be pregnant or breastfeeding.
- Be unwilling to use contraception if of childbearing potential.
- Have other cancers within the last 3 years, except for certain treated cancers.
- Have fluid buildup in the chest or abdomen causing breathing issues.
- Be unsuitable for the study in the opinion of the doctor.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic in Arizona | 85259 | Scottsdale | Arizona |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| MedStar Georgetown University Hospital | 20007 | Washington D.C. | District of Columbia |
| Mayo Clinic in Florida | 32224 | Jacksonville | Florida |
| Emory University Hospital/Winship Cancer Institute | 30322 | Atlanta | Georgia |
| University of Chicago Comprehensive Cancer Center | 60637 | Chicago | Illinois |
| University of Iowa/Holden Comprehensive Cancer Center | 52242 | Iowa City | Iowa |
| Siouxland Regional Cancer Center | 51101 | Sioux City | Iowa |
| Cancer Center of Kansas | 67214 | Wichita | Kansas |
| Mayo Clinic | 55905 | Rochester | Minnesota |
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