At a glance
ClinicalIndex Comparison Record- ✓Histologically proven left-sided metastatic colorectal cancer
- ✓RAS/BRAF wild-type and pMMR and/or MSS status
- ✓Disease judged unresectable by multidisciplinary team
- ✓Candidate for induction with FOLFIRI plus panitumumab
- ✕Prior malignancy within 5 years (except skin/cervical cancers with curative therapy)
- ✕Prior chemotherapy for mCRC (adjuvant >6 months prior allowed)
- ✕Major surgery within 4 weeks prior to enrollment
- ✕Pregnancy and breast-feeding
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Panitumumab, Irinotecan, and 2 other interventions for Colorectal Cancer Stage IV. Currently recruiting, targeting 500 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Administered at the dosage of 6mg/kg as 60 minutes, or 90 minutes for doses over 1000 mg, intravenous infusion
Administered at the dosage of 180 mg/m2 over 60 minutes intravenous infusion
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
Administered at the dosage of 200 mg/m2 over 120 minutes as intravenous infusion