NCT02271464

Maintenance Bevacizumab Only or Bevacizumab Plus Metronomic Chemotherapy in Advanced Colorectal Cancer

Phase II Randomized Study of Maintenance Treatment With Bevacizumab or Bevacizumab Plus Metronomic Chemotherapy After First-line Induction FOLFOXIRI Plus Bevacizumab for Metastatic Colorectal Cancer Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 232 (actual)
• Sponsor: Azienda Ospedaliero, Universitaria Pisana · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study consist of 4-months induction first-line chemotherapy with the G.O.N.O. FOLFOXIRI regimen plus bevacizumab followed by maintenance with bevacizumab or bevacizumab plus metronomic chemotherapy (with capecitabine and cyclophosphamide) in mCRC patients. The main objective of this study is to preliminarily evaluate the potential effects of the combination of a metronomic chemotherapy with capecitabine and cyclophosphamide to maintenance bevacizumab on pharmacodynamic and clinical parameters among mCRC patients.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Maintenance:BEVACIZUMAB	Patients will be randomly assigned to receive induction chemotherapy with the G.O.N.O. FOLFOXIRI regimen plus bevacizumab: * BEVACIZUMAB 5 mg/kg over 30 minutes, day 1 * IRINOTECAN 165 mg/sqm IV over 1-h, day 1 * OXALIPLATIN 85 mg/sqm IV over 2-h, day 1 * L-LEUCOVORIN 200 mg/sqm IV over 2-h, day 1 * 5-FLUOROURACIL 3200 mg/sqm IV 48-h continuous infusion, starting on day 1 with cycles repeated every 2 weeks for 4 months (8 cycles), followed after 2 weeks by (if no progression occurs): \- BEVACIZUMAB 7.5 mg/kg over 30 minutes, day 1 (every three weeks)
DRUG	Maintenance:BEVACIZUMAB+CAPECITABINE+CYCLOPHOSPHAMIDE	Patients will be randomly assigned to receive induction chemotherapy with the G.O.N.O. FOLFOXIRI regimen plus bevacizumab: * BEVACIZUMAB 5 mg/kg over 30 minutes, day 1 * IRINOTECAN 165 mg/sqm IV over 1-h, day 1 * OXALIPLATIN 85 mg/sqm IV over 2-h, day 1 * L-LEUCOVORIN 200 mg/sqm IV over 2-h, day 1 * 5-FLUOROURACIL 3200 mg/sqm IV 48-h continuous infusion, starting on day 1 with cycles repeated every 2 weeks for 4 months (8 cycles), followed after 2 weeks by (if no progression occurs): * BEVACIZUMAB 7.5 mg/kg over 30 minutes, day 1 (every three weeks), * CAPECITABINE 500 mg/tid orally, continuously, * CYCLOPHOSPHAMIDE 50 mg/day orally, continuously.

Timeline

• Start date: 2012-03-01
• Primary completion: 2017-03-01
• Completion: 2017-09-01
• First posted: 2014-10-22
• Last updated: 2017-12-07

Locations

20 sites across 1 country: Italy