TACE With Irinotecan Drug-eluting Beads and Intravenous (IV) Cetuximab in Refractory Colorectal Cancer

Sponsor
Hans-Joachim Schmoll, MD
Study ID
NCT01060423
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cetuximab — DRUG
    Starting dose of 400mg/m2, followed by weekly 250mg/m2
  • Irinotecan — DRUG
    Irinotecan 180 mg/m² to be administered every two weeks
  • Irinotecan eluting BEADS — DEVICE
    A minimum of two treatments per lobe (four bi-weekly sessions in the event of bilobar disease) at week 0 and 4 with up to 4ml (100-300µm DC Bead loaded with up to 200mg irinotecan) will be scheduled (i.e. for bilobar disease right lobe: week 0, left lobe: week 2, right lobe: week 4 and left lobe: week 6: following toxicity and extending interval if toxicity seen).

Study Details

The primary objective of this study is to evaluate the efficacy of Irinotecan Beads in combination with intravenous cetuximab versus intravenous irinotecan in combination with intravenous cetuximab in the treatment of patients with unresectable liver metastases from colorectal cancer. Secondary objectives are safety and tolerability of hepatic chemoembolization and the question if the addition of aprepitant to standard antiemetic prophylaxis in patients treated by hepatic chemoembolization is safe and will reduce the rate of acute and delayed nausea and emesis.

Key Dates

Start date
Feb 28, 2010
Status verified
Oct 2016
Primary completion
Dec 31, 2012
Completion
May 31, 2015

Study Design

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

Arms

  • Experimental: hepatic TACE with irinotecan eluting beads and iv cetuximab
    Irinotecan drug-eluting beads administered by hepatic chemoembolization with intravenous cetuximab (DEBIRITUX)
  • Active Comparator: iv cetuximab and irinotecan
    systemic treatment with intravenous cetuximab and irinotecan

Primary Outcome Measure

Progression free survival rate [ Time Frame: 6 months after first administration of study medication ]

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