NCT04587128

Early-Line Anti-EGFR Therapy to Facilitate Retreatment for Select Patients With mCRC

Phase II Trial of Early-Line Anti-EGFR Therapy to Facilitate Retreatment for Select Patients With Metastatic Colorectal Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will use previously established doses of panitumumab or cetuximab in the metastatic setting for the treatment of unresectable colorectal cancer (CRC). It is designed to investigate an alternative treatment strategy to maximize the benefit to inhibition of epidermal growth factor receptor (EGFR) for a highly selected patient population. It will enroll 71 participants with left-sided, unresectable metastatic CRC. Participants will be on study up to 5 years.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Panitumumab	Epidermal growth factor receptor inhibitor, anti-neoplastic
DRUG	Cetuximab	Epidermal growth factor receptor inhibitor, anti-neoplastic
DRUG	Irinotecan	anti-neoplastic, chemotherapy drug
DRUG	FOLFIRI Protocol	folinic acid (also called leucovorin, calcium folinate or FA) fluorouracil (also called 5FU) irinotecan given per institutional standard (intravenously day 1 and day 15 of 28 day cycle) alternating and not concomitant with panitumumab or cetuximab
DRUG	Bevacizumab	Bevacizumab (or biosimilar) may be administered with FOLFIRI per treating MD discretion and will be given per institutional standard (5 mg/kg intravenously day 1 and day 15 of 28 day cycle)

Timeline

• Start date: 2020-10-19
• Primary completion: 2029-10-01
• Completion: 2029-10-01
• First posted: 2020-10-14
• Last updated: 2026-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study