Drug-Eluting Bead, Irinotecan (DEBIRI) Therapy of Liver Metastasis From Colon Cancer With Systemic Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab

Conditions

• Colon Cancer With Metastases to the Liver

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• LC beads loaded with Irinotecan — DEVICE
  Chemoembolization using LC beads loaded with 100mg Irinotecan
• Oxaliplatin — DRUG
  Oxaliplatin 85 mg/sqm, IV infusion every two weeks
• Leucovorin — DRUG
  Leucovorin 200 mg/sqm, IV infusion every two weeks
• 5-Fluorouracil — DRUG
  5-Fluorouracil 2400 mg/sqm, IV infusion every 2 week
• Bevacizumab — DRUG
  Bevacizumab 5 mg/kg given at the discretion of the treating physician

Study Details

This is a multicentre, open labeled, controlled phase study designed to assess effectiveness of chemoembolization with LC Beads, both with and without systemic chemotherapy, in the treatment of unresectable liver metastases in patients with colorectal cancer.

Key Dates

First listed

Jul 3, 2009

Start date

Jun 30, 2009

Status verified

Mar 2018

Primary completion

Dec 31, 2012

Completion

Dec 31, 2012

Study Design

Enrollment

70 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: LC Beads loaded with Irinotecan and FOLFOX6
  Device: LC Beads loaded with 100mg Irinotecan Drug: Systemic Chemotherapy (FOLFOX6) Oxaliplatin 85 mg/sqm, IV infusion every two weeks Leucovorin 200mg/sqm, IV infusion every two weeks 5-Fluorouracil 2400mg/sqm, IV infusion every two weeks Bevacizumab 5mg/kg given at the discretion of treating physician
• Active Comparator: FOLFOX6 and Bevacizumab
  Drug: Systemic Chemotherapy (FOLFOX6) Oxaliplatin 85 mg/sqm, IV infusion every two weeks Leucovorin 200mg/sqm, IV infusion every two weeks 5-Fluorouracil 2400mg/sqm, IV infusion every two weeks Bevacizumab 5mg/kg given at the discretion of treating physician

Primary Outcome Measure

Tumor Response [ Time Frame: Months 2, 4 and 6 ]

Locations (9)

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