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

Sponsor
Azienda Ospedaliero, Universitaria Pisana
Study ID
NCT02271464
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Maintenance:BEVACIZUMAB — DRUG
    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)
  • Maintenance:BEVACIZUMAB+CAPECITABINE+CYCLOPHOSPHAMIDE — DRUG
    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.

Study Details

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.

Key Dates

First listed
Oct 22, 2014
Start date
Mar 31, 2012
Status verified
Dec 2017
Primary completion
Mar 31, 2017
Completion
Sep 30, 2017

Study Design

Enrollment
232 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Maintenance:BEVACIZUMAB
    Induction: FOLFOXIRI; Manteinance: Bevacizumab
  • Experimental: Maintenance:BEVACIZUMAB+CAPECITABINE+CYCLOPHOSPHAMIDE
    Induction: FOLFOXIRI; Maintenance:BEVACIZUMAB+CAPECITABINE+CYCLOPHOSPHAMIDE(Metronomic Chemotherapy)

Primary Outcome Measure

progression-free survival (PFS) [ Time Frame: up to 4 years ]

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