NCT02295930

Induction Chemoterapy With Folfoxiri Plus Cetuxumab in Unresectable Colorectal Cancer Patient

Induction Chemotherapy With Folfoxiri Plus Cetuximab and Maintenance With Cetuximab or Bevacizumab Therapy in Unresectable Kras Wild-type Metastatic Colorectal Cancer Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Gruppo Oncologico del Nord-Ovest · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II randomized study of 4-months induction first-line chemotherapy with FOLFOXIRI + cetuximab followed by maintenance with cetuximab or bevacizumab in patients affected by KRAS wild type (wt) mCRC.

Detailed description

The aim of the study is to obtain a rapid disease control with the therapy and the maximum tumoral shrinkage, and than to treat patient with less intensive maintenance to inhibit tumoral regrowth.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
OTHER	folfoxiri+cetuximab+surgery+cetuximab	Induction FOLFOXIRI plus cetuximab will consist of: * CETUXIMAB 500 mg/sqm IV over 1-h\* , day 1 followed by * IRINOTECAN 130 mg/sqm IV over 1-h, day 1 followed by * OXALIPLATIN 85 mg/sqm IV over 2-h, day 1 concomitantly with * l-LV 200 mg/sqm IV over 2-h, day 1 followed by * 5-FLUOROURACIL 2400 mg/sqm IV 48-h continuous infusion, starting on day 1 repeated every 2 weeks for 8 cycles. Surgical revaluation will be performed after the induction phase (8 cycles). Patients deemed unsuitable for surgery will received maintenance treatment as follows: •CETUXIMAB 500 mg/sqm IV over 60-min, day 1 repeated every 2 weeks until PD, patient's refusal, unacceptable toxicity or consent withdrawal.
OTHER	folfoxiri+cetuximab+surgery+bevacizumab	Induction FOLFOXIRI plus cetuximab will consist of: * CETUXIMAB 500 mg/sqm IV over 1-h\* , day 1 followed by * IRINOTECAN 130 mg/sqm IV over 1-h, day 1 followed by * OXALIPLATIN 85 mg/sqm IV over 2-h, day 1 concomitantly with * l-LV 200 mg/sqm IV over 2-h, day 1 followed by * 5-FLUOROURACIL 2400 mg/sqm IV 48-h continuous infusion, starting on day 1 repeated every 2 weeks for 8 cycles. Surgical revaluation will be performed after the induction phase (8 cycles). Patients deemed unsuitable for surgery will received maintenance treatment as follows: •BEVACIZUMAB 5 mg/kg IV over 30-min, day 1 repeated every 2 weeks until PD, patient's refusal, unacceptable toxicity or consent withdrawal.

Timeline

• Start date: 2011-10-01
• Primary completion: 2015-03-01
• First posted: 2014-11-20
• Last updated: 2015-03-12

Locations

22 sites across 1 country: Italy