Panitumumab Rechallenge versus Standard Therapy for RAS Wild-Type Colorectal Cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn if panitumumab rechallenge is more effective for your cancer than standard therapy of TAS-102 or regorafenib.

What is the Condition Being Studied?

Colorectal Cancer

Who Can Participate in the 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)

Age Group
Adults

What is Involved?

You have previously participated in the COLOMATE study and were matched to this study based on the type of cancer you have and the mutations that your cancer cells have.

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

Study Details

Full Title
PULSE: A Randomized, Phase II Open Label Study of PanitUmumab RechaLlenge Versus Standard Therapy after Progression on Anti-EGFR Therapy in Patients with Metastatic and/or Unresectable RAS Wild-Type Colorectal Cancer
Principal Investigator
Medical Oncologist
Protocol Number
IRB: PRO00104206
NCT: NCT03992456
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698