Early-Line Anti-EGFR Therapy to Facilitate Retreatment for Select Patients With mCRC (NCT04587128)

🧪 Interventions in This Study

• Panitumumab (DRUG)
• Cetuximab (DRUG)
• Irinotecan (DRUG)
• FOLFIRI Protocol (DRUG)
• Bevacizumab (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Written informed consent and HIPAA authorization for release of personal health information
2. As determined by the enrolling physician or protocol designee, ability of the participant to understand and comply with study procedures for the entire length of the study
3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
4. Have a diagnosis of histologically confirmed metastatic colorectal cancer with primary tumor located beyond the splenic flexure. Histologic confirmation of a colorectal primary tumor is acceptable if accompanied by radiographic evidence of metastatic disease.
5. For Cohort A: Participants must enroll for study treatment in the first or second-line metastatic setting. Participants may receive 1 month of standard chemotherapy in the metastatic setting and still be eligible to initiate protocol therapy in the first-line setting. Adjuvant or neoadjuvant therapy does not count as a line of therapy even if given in the setting of metastatic disease (oligometastatic), unless disease recurrence was noted within 6 months of completing the last dose of the adjuvant or neoadjuvant therapy.
6. For Cohort B: Participants must have had at least stable disease (per treating physician) on a prior EGFR inhibitor containing regimen and it must be at least 4 months since the prior anti-EGFR inhibitor treatment was completed. Participants previously enrolled in Cohort A can later enroll in Cohort B should the eligibility criteria be met.
7. For Cohort C: Subjects with no prior use of irinotecan or anti-EGFRi. If patients were treated on cohort A (of this study) they can cross-over to cohort C if other eligibility criteria are met at the time of cross-over.
8. Evaluable disease according to RECIST v1.1. Participants do not have to have measureable disease.
9. Participants with prior brain metastasis may be considered if they have completed their treatment for brain metastasis at least 4 weeks prior to study registration, have been off of corticosteroids for ≥ 2 weeks, and are asymptomatic.
10. Demonstrate adequate organ function; all screening labs to be obtained within 7 days prior to registration. Note minimum platelet requirement differs between Cohort A and B.
11. Absolute Neutrophil Count (ANC) ≥ 1,000 / mcL
12. Platelets ≥ 50,000 / mcL (Cohort A); ≥ 50,000 mcL (Cohort B receiving only EGFRi); ≥75,000 / mcL (cohort B receiving irinotecan and EGFRi; and cohort C)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

• University of Wisconsin Carbone Cancer Center — Madison, Wisconsin

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
• 💵 Compensation indicated: Participants may receive 1 month of standard chemotherapy in the metastatic setting and still be eligible to initiate protocol therapy in the first-line setting.

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💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.