RecruitingPhase 3NCT06509126

Intermittent or Continuous Panitumumab Plus FOLFIRI for Left Sided RAS/B-RAF Wild-type Metastatic Colorectal Cancer

Randomized Phase 3 Study of Intermittent or Continuous Panitumumab Plus FOLFIRI for First-line Treatment of Patients With Unresectable Left Sided RAS/B-RAF Wild-type Metastatic Colorectal Cancer (IMPROVE-2 Trial)

Sponsor

National Cancer Institute, Naples

Enrollment

500 participants

Start Date

Jun 12, 2024

Study Type

INTERVENTIONAL

Conditions

Colorectal Cancer Stage IV

Summary

The investigators hypothesize that intermittent first-line Panitumumab plus FOLFIRI is effective in first line as the same regimen given continuously, resulting in a Time to Treatment Failure (TTF) not inferior to that obtained with standard continuous regimen of Panitumumab plus FOLFIRI, in the treatment of metastatic left sided RAS/B-RAF wild-type colorectal cancer patients. Correlative mechanistic studies on tissue and blood samples, liquid biopsies, could identify potential biomarkers of efficacy and help understanding the evolutionary dynamics of tumors in response to therapy thus optimizing the treatment approach with a personalized anti-EGFR treatment strategy.

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two ways of giving a targeted cancer drug called panitumumab — either continuously throughout treatment or in an intermittent "on and off" schedule — alongside standard chemotherapy (FOLFIRI) for patients with metastatic colorectal cancer on the left side of the colon that cannot be surgically removed. **You may be eligible if...** - You have been diagnosed with metastatic colorectal cancer that originated on the left side of the colon - Your cancer has certain genetic characteristics (RAS/BRAF wild-type and stable microsatellites) - You have not yet received any chemotherapy or radiation for your metastatic cancer - Your doctors have recommended treatment with FOLFIRI plus panitumumab as standard care - You are 18 or older and in acceptable overall health **You may NOT be eligible if...** - You have already received treatment for metastatic colorectal cancer - Your cancer has different genetic markers (e.g., RAS or BRAF mutations) - You have other serious health conditions that prevent standard chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPanitumumab

Administered at the dosage of 6mg/kg as 60 minutes, or 90 minutes for doses over 1000 mg, intravenous infusion

DRUGIrinotecan

Administered at the dosage of 180 mg/m2 over 60 minutes intravenous infusion

DRUG5-fluorouracil

Administered at the dosage of 400 mg/m2 (bolus intravenous infusion) followed by continuous intravenous infusion over 46 hours at the dosage of 2400 mg/m2

DRUGL-folinic acid

Administered at the dosage of 200 mg/m2 over 120 minutes as intravenous infusion

Locations(1)

Istituto Nazionale Tumori di Napoli - IRCCS - Fondazione G. Pascale

Naples, Italy

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NCT06509126

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