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Prognostic Factors for Patients With Advanced Colorectal Cancer Treated With Cetuximab.

NCT01068132 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2014-05-12

No results posted yet for this study

Summary

Italian, multicentre, non comparative trial in patients with advanced Colorectal Cancer(CRC)and KRAS wild-type, defined by molecular evaluation.

Patients will receive Cetuximab + FOLFIRI until disease progression, unacceptable toxicity developed or patient refusal.

The aim of this study is to assess the prognostic role of PTEN in terms of Progression free survival.

Although the role of Cetuximab as first line treatment in metastatic CRC will be soon established, it is still unclear which is the best schedule for Cetuximab and the role of biological factors in order to select the most appropriate subset of pts for recommending Cetuximab. The data supporting a benefit of Cetuximab in KRAS wild-type pts open the perspective to study the role of other molecular markers in this subset of pts.

On the basis of these considerations this study is aimed at testing a different schedule of Cetuximab and better characterize the prognosis of pts for which Cetuximab is appropriate.

Conditions

Interventions

DRUG

Cetuximab

cetuximab 500 mg/ m² starting dose, following everytwo- week doses of 500 mg/ m², given d1,

DRUG

FOLFIRI

irinotecan 180 mg/m2 on day 1 with LV 100 mg/m2 administered as a 2-hour infusion before FU 400 mg/m2 administered as an intravenous bolus injection, and FU 600 mg/m2 as a 22-hour infusion immediately after FU bolus injection on days 1 and 2

Sponsors & Collaborators

  • Mario Negri Institute for Pharmacological Research

    collaborator OTHER

  • Istituto Clinico Humanitas

    collaborator OTHER

  • A.O. Ospedale Papa Giovanni XXIII

    collaborator OTHER

  • Regione Lombardia

    lead OTHER

Principal Investigators

  • Roberto Labianca, MD · A.O. Ospedale Papa Giovanni XXIII

  • Armando Santoro, MD · Istituto Clinico Humanitas

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Italy

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 NCT01068132 on ClinicalTrials.gov