Panitumumab Rechallenge versus Standard Therapy for RAS Wild-Type Colorectal Cancer
What is the Purpose of this Study?
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 (a fair 50/50 chance) to either Group 1 or Group 2
-----Group 1 will get the study drug, panitumumab, intravenously (into the vein) on Day 1 and Day 15 of each 28 day cycle.
-----Group 2 will get either TAS-102 or regorafenib (this will be decided by your physician)
-----------If you take TAS-102, you will take pills by mouth twice daily on days 1-5 and days 8-12 every 28 days.
-----------If you take regorafenib, you will take pills by mouth once daily on days 1-21 every 28 days.
-Have physical exams, lab tests, and other tests done throughout the study
Who Can Participate in this Study?
Adults, 18+ who:
-Registered to COLOMATE ACCRU-GI-1611 and were matched to this trial
-Have a history of adenocarcinoma of the colon or rectum that is metastatic and/or unresectable.
-Cancer worsened after treatment with cetuximab and/or panitumumab for at least 4 months
-Are able to provide a tumor sample or have a fresh biopsy of their tumor
-Have not had both TAS-102 and regorafenib (prior treatment with either TAS-102 or regorafenib is permitted)
What is Involved?
We are doing this study to learn if panitumumab rechallenge is more effective for your cancer than standard therapy of TAS-102 or regorafenib.