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

NCT04587128 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-02-05

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • Doris Duke Charitable Foundation

    collaborator OTHER

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Dustin Deming, MD · University of Wisconsin, Madison

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-19
Primary Completion
2029-10-31
Completion
2029-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04587128 on ClinicalTrials.gov