Colorectal Cancer: S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride
in Treating Patients With Locally Advanced or Metastatic HER2/Neu Amplified Colorectal
Cancer That Cannot Be Removed by Surgery
Research Question:
What are the good and bad effects of using a combination of antibodies called trastuzumab
and pertuzumab compared to using the usual chemotherapy of cetuximab and irinotecan?
Basic Study Information
Purpose:
If you decide to participate in this study a computer will assign you to one of the
3 study groups. This is done by chance because no one knows if one study group is
better or worse than the other. Group 1 will receive the study drugs trastuzumab and
pertuzumab. The combination of trastuzumab and pertuzumab is investigational (not
approved by the FDA for treatment of colorectal cancer). These drugs will be given
through a vein on Day 1 of every 21 day cycle. Group 2 will receive the usual chemotherapy,
cetuximab and irinotecan, through a vein on Day 1 of every 14 day cycle. If you are
in Group 2 and your cancer gets worse, you may have the option to receive the same
treatment as Group 1, and be placed into Group 3.
Location: Cancer Center
Study Web URL: https://clinicaltrials.gov/ct2/show/NCT03365882?term=S1613&rank=1
Study Reference #: CGIC17126
Lead Researcher (Principal Investigator)
Lead Researcher: Marcus Noel
Study Contact Information
Study Coordinator: Tanya Smith
Phone: (585) 275-8213
Email: Tanya_Smith@URMC.Rochester.edu
Additional Study Details
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