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

NCT00689624 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-09-28

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Irinotecan

Irinotecan will be administered at a dose of 150mg/m2 as a 30 min IV infusion on day 1

DRUG

Leukovorin

Leukovorin will be administered at a dose of 200mg/m2 as a 2-hour IV infusion on days 2 and 3

DRUG

Oxaliplatin

Oxaliplatin will be administered on day 2 at the dose of 65mg/m2 as a 2-hours IV

DRUG

5-FLUOROURACIL

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

DRUG

Cetuximab

Cetuximab will be administered at the dose of 500mg/m2 as a 2-hour infusion on day 1 at least one hour before chemotherapy

Sponsors & Collaborators

  • University Hospital of Crete

    lead OTHER

Principal Investigators

  • John Souglakos, MD · University Hospital of Crete

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Greece

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00689624 on ClinicalTrials.gov