ANGIOPREDICT. ICORG 12-16, V3

Advanced Colorectal Cancer Clinical Trial

Official title: Exploratory Phase II Clinical Trial Comprising Biomarker Analysis of Oxaliplatin Plus Fluorouracil/Leucovorin (FOLFOX) in Combination With Bevacizumab (Bvz) in First Line Treatment of Metastatic Colorectal Cancer (CRC) Expressing Mutant K-ras - AC-ANGIOPREDICT

Status Completed

Clinical Trial Summary

Primary Objective:

The primary objective is to validate previously identified predictive/prognostic genomic DNA and expression biomarkers of response to combination bvz treatments in K-ras mutant advanced CRC (a CRC) or metastatic CRC (mCRC).

Secondary Objective:

1. To test the efficacy of bvz in combination with FOLFOX in patients with newly diagnosed advanced or metastatic K-ras mutant CRC and

2. To determine the progression free and overall survival of patients under first line FOLFOX + bvz in aCRC or mCRC.

Clinical Trial Description

Study Design:

Type of Study: Exploratory, translational, multicenter and multinational Phase II study.

Patient Population:All patients from the intent-to-treat population with aCRC or mCRC, (incurable with any conventional multimodality approach) and who fulfil all inclusion and exclusion criteria.

Number of Patients: 224

Sample Type:

Serial tissue and blood samples will be collected before (week 0), during (week 6, month 3 and 6) and at the end of treatment (month 12). ;

Related Conditions & MeSH terms

• Advanced Colorectal Cancer
• Colorectal Neoplasms

• NCT number: NCT01822444
• Study type: Observational
• Source: Cancer Trials Ireland
• Status: Completed
• Start date: November 2012
• Completion date: February 2017