Regorafenib and Anti-EGFR with Reverse Sequencing in Metastatic Colorectal Cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to compare the effects, good and/or bad, of taking regorafenib followed by cetuximab or panitumumab to those that receive cetuximab or panitumumab before regorafenib.

Other studies suggest that the order of treatment may improve outcomes in people with colorectal cancer.

What is the Condition Being Studied?

Colorectal Cancer

Who Can Participate in the Study?

Adults, 18+ who:
-Have a history of adenocarcinoma of the colon or rectum that is metastatic and unresectable or locally advanced.
-Cancer worsened after treatment with fluoropyrimidine, oxaliplatin, and irinotecan or you are unable to take those drugs
-Have not had regorafenib, cetuximab, or panitumumab

Age Group
Adults

What is Involved?

If you choose to join this study you will:
-Go through a screening period which will last about 4 weeks
-Have physical exams
-Have lab tests and other screening tests to see if you qualify for the study

If you’re able to join, you will:
-Be randomly assigned to either Group 1 or Group 2
-----Group 1 will take the study dug, regorafenib, by mouth once a day for each 28 day cycle
-----Group 2 will get either Cetuximab or Panitumuab as an intravenous infusion (into the vein) with or without irinotecan (this will be decided by your doctor) on days 1 and 15 of each 28 day cycle
-Have physical exams, lab tests, and other tests done throughout the study

Study Details

Full Title
A Randomized Phase II Study of Regorafenib Followed by Anti-EGFR monoclonal antibody therapy Versus the Reverse Sequencing for metastatic colorectal cancer patients previously treated with fluoropyrimidine, oxaliplatin and irinotecan (REVERCE II)
Principal Investigator
Medical Oncologist
Protocol Number
IRB: PRO00104828
NCT: NCT04117945
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698