NCT04034173

Optimal Anti-EGFR Treatment of mCRC Patients With Low-Frequency RAS Mutation

FIRE-5 -Study: Optimal Anti-EGFR Treatment of mCRC Patients With Low-Frequency RAS Mutation

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Ludwig-Maximilians - University of Munich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The present hypothesis is that anti-EGFR agents are active in tumors with low-level RAS mutation when the majority of tumor cells is still sensitive. While response rate may be high and may reflect sensitivity to anti-EGFR agents, PFS is anticipated to be shorter than in RAS wild-type patients due to the faster development of resistance when sensitive cells are eradicated and when the RAS-mutant anti-EGFR resistant clones become predominant. The characteristics of low-level RAS mutant tumors would be: * Objective response rate (ORR) high (reflecting the sensitive clone) * Progression-free survival (PFS) short (reflecting the more rapid outgrowth of RAS mutant clones)

Conditions

• Treatment Related Cancer

Interventions

Type	Name	Description
DRUG	Panitumumab	Panitumumab 6 mg/kg BW as 60-min i.v. infusion\* D1 \*If the 1st infusion is well tolerated, all subsequent infusions can be applied over 30-60 minutes.
DRUG	Irinotecan	Irinotecan 180 mg/m² BSA i.v., 30 - 90 min D1
DRUG	Folinic acid	Folinic acid (racemic) 400 mg/m²BSA i.v., 120 min D1
DRUG	5-FU	5-FU 400 mg/m² BSA, bolus, D1 5-FU 2400 mg/m² BSA i.v. infusion over a period of 46 h D1-2

Timeline

• Start date: 2019-08-01
• Primary completion: 2024-08-01
• Completion: 2026-08-01
• First posted: 2019-07-26
• Last updated: 2019-07-26

Locations

1 site across 1 country: Germany