Intra-arterial Hepatic Bevacizumab and Systemic Chemotherapy

Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Study ID
NCT01677884
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    Every 3 weeks : 7.5 mg/kg intra arterial in 2 hours at D1
  • Capecitabine — DRUG
    Every 3 weeks: 2000 mg/m²/d in 2 times/d from D1 to D4
  • Irinotecan — DRUG
    Every 3 weeks: 200mg/m² in 30mn IV at D1 (if oxaliplatin in first line) or oxaliplatin 130mg/m² in 2h IV at D1 (if irinotecan in first line)

Study Details

The purpose of the study is to assessed the efficiency of treatment based on the objective response rate (RECIST 1.1)

Key Dates

Start date
Nov 30, 2012
Status verified
Jun 2016
Primary completion
Feb 29, 2016
Completion
Feb 29, 2016

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients with metastatic CRC

Primary Outcome Measure

Efficiency of treatment based on objective response rate [ Time Frame: Every 9 weeks from the start to tumoral progression ]

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