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

Phase 2

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: Cetuximab; Drug: FOLFIRI

• Registration Number: NCT01068132
• Lead Sponsor: Regione Lombardia

Brief 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.

Detailed Description

Pts meeting eligibility criteria will be registered, providing the availability of material for molecular analysis. Tumour specimens and blood sample will be collected to perform genomic, ICH and proteomic analyses in order to identify the molecular characteristics of tumour.

After the availability of KRAS evaluation, only the data of KRAS wild-type pts will be collected.

Access to registration system will be allowed via web.

Patients,KRAS wild-type receive:

- Cetuximab+FOLFIRI: cetuximab 500 mg/ m² starting dose, following everytwo- week doses of 500 mg/ m², given d1, followed after 1 hour by 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

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-05-04
• Study First Submitted QC: 2010-02-11
• Study First Posted: 2010-02-12
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-09
• Last Update Posted: 2014-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Cetuximab	Cetuximab+FOLFIRI: cetuximab 500 mg/ m² starting dose, following everytwo- week doses of 500 mg/ m², given d1, followed after 1 hour by 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
1	FOLFIRI	Cetuximab+FOLFIRI: cetuximab 500 mg/ m² starting dose, following everytwo- week doses of 500 mg/ m², given d1, followed after 1 hour by 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

Primary Outcome Measures

Name	Time	Method
Progression free survival	untill 48 months

Secondary Outcome Measures

Name	Time	Method
Overall survival	untill 48 months

Trial Locations

Locations (7)

Ospedale Morelli Sondalo; 🇮🇹 Sondalo, Sondrio, Italy

Ospedali Riuniti di Bergamo; 🇮🇹 Bergamo, Italy

Ospedale di Treviglio e Caravaggio; 🇮🇹 Treviglio, Bergamo, Italy

Ospedale di Saronno; 🇮🇹 Saronno, Varese, Italy

Istututo Clinico Humanitas; 🇮🇹 Rozzano, Milano, Italy

IRCCS San Raffaele; 🇮🇹 Milano, Italy

Ospedale di Sondrio; 🇮🇹 Sondrio, Italy