Irinotecan/Oxaliplatin/5-Fluorouracil/Leucovorin/Cetuximab As First Line Treatment In Colorectal Cancer

Sponsor
University Hospital of Crete
Study ID
NCT00689624
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan — DRUG
    Irinotecan will be administered at a dose of 150mg/m2 as a 30 min IV infusion on day 1
  • Leukovorin — DRUG
    Leukovorin will be administered at a dose of 200mg/m2 as a 2-hour IV infusion on days 2 and 3
  • Oxaliplatin — DRUG
    Oxaliplatin will be administered on day 2 at the dose of 65mg/m2 as a 2-hours IV
  • 5-FLUOROURACIL — DRUG
    5-FLUOROURACIL at the dose of 400mg/m2 as IV bolus and then, 600mg/m2 as a 22-hour continuous IV infusion, on days 2 and 3
  • Cetuximab — DRUG
    Cetuximab will be administered at the dose of 500mg/m2 as a 2-hour infusion on day 1 at least one hour before chemotherapy

Study Details

This study will evaluate the efficacy of FOLOFOXIRI plus Cetuximab combination in young patients with good performance status with unresectable metastatic colorectal cancer.

Key Dates

Start date
Jul 31, 2007
Status verified
Sep 2015
Primary completion
Dec 31, 2010
Completion
Dec 31, 2010

Study Design

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

Arms

  • Experimental: 1
    FOLFOXIRI+Erbitux

Primary Outcome Measure

Objective Response Rate [ Time Frame: 2 months ]

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