FOLFOX 4 + CETUXIMAB IN UNTREATED PATIENTS WITH ADVANCED COLO-RECTAL TUMOUR. A PHASE II MULTICENTER STUDY OF THE GRUPPO ONCOLOGICO DELL'ITALIA MERIDIONALE - ND

• Conditions: ADVANCED COLO-RECTAL TUMOUR; MedDRA version: 9.1Level: LLTClassification code 10010029Term: Colorectal cancer NOS

• Registration Number: EUCTR2004-004181-32-IT
• Lead Sponsor: OSPEDALE ONCOLOGICO DI BARI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. LOCALLY ADVANCED OR METASTATIC UNRESECTABLE COLO-RECTAL CARCINOMA 2. IMMUNOHISTOCHEMICAL EVIDENCE OF EGFR EXPRESSION IN THE PRIMITIVE TUMOUR AND/OR IN A METASTASIS AT LEAST 3. PRESENCE OF A MEASURABLE LESION AT LEAST 4. AGE BETWEEN 18 AND 75 YEARS OLD 5. LIFE EXPECTANCY >= 3MONTHS
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. BRAIN METASTASIS 2. PREVIOUS CHEMOTHERAPY 3. PREVIOUS EXPOSURE TO EGF, MONOCLONAL ANTIBODIES, INHIBITORS OF THE TRANSDUCTION SIGNAL OR THERAPY HAVING THE EGFR AS A TARGET 4. PERIFERIC NEUROPATY 5. ALLERGIC REACTIONS TO THE COMPONENTS OF THE TREATMENT 6. PREGNANCY AND BREAST-FEEDING 7. OTHER TUMOURS

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: PERCENTAGE OF OBJECTIVE RESPONSES;Primary end point(s): TO ESTIMATE THE PERCENTAGE OF OBJECTIVE RESPONSES;Secondary Objective: 1. TOXICITY OF THE COMBINATION 2. AVERAGE TIME FOR THE FAILURE OF THE TREATMENT 3. AVERAGE TIME TO PROGRESSION 4. TOTAL SURVIVAL 5. PERCENTAGE OF RESECTIONS OF THE LIVER/LUNG METASTASIS AFTER THE TREATMENT 6. CORRELATION BETWEEN THE EXPRESSION LEVELS OF THE EGF RECEPTOR AND THE OBJECTIVE RESPONSES 7. CORRELATION BETWEEN SKIN TOXICITY AND THE OBJECTIVE RESPONSES