Yttrium Microspheres With Cetuximab Plus Irinotecan for Patients With Advanced Colorectal Cancer Mets to Liver

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00766220
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • SIR-spheres Agent Administration — DRUG
    SIR-Spheres, resin microspheres containing pure Beta emitter Yttrium-90, given through femoral catheter over 10 minutes.
  • Cetuximab — DRUG
    400 mg/m2 by vein over 2 hours once a week. Cetuximab infusions will be continued weekly at a dose of 250 mg/m2 unless toxicity necessitates interruptions.
  • Irinotecan — DRUG
    350 mg/m2 (or 300 mg/m2 in patients who are greater or equal to 70 years of age, or have an ECOG PS of 2 or have had prior pelvic and/or abdominal irradiation), by vein over 90 minutes, every three weeks.

Study Details

The goal of this clinical research study is to find out what effects radioactive particles, SIR-spheres, have when injected into the liver, followed by systemic chemotherapy with a combination of cetuximab and irinotecan compared to those who have systemic therapy alone, in patients with colon cancer that has metastasized to the liver. The safety of this treatment and how well it controls the disease will also be studied.

Key Dates

Start date
Oct 31, 2009
Status verified
Dec 2012
Primary completion
Jan 31, 2012
Completion
Jan 31, 2012

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: SIR-Spheres + Therapy
    SIR-Spheres with Cetuximab + Irinotecan Therapy
  • Active Comparator: Therapy Only
    Cetuximab + Irinotecan Therapy

Primary Outcome Measure

Progression Free Survival [ Time Frame: 4 Months ]

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