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Predictive Factors for the Optimization of Cetuximab in the Treatment of Patients With Advanced Colorectal Cancer

2014-08-27 03:15:55 | BioPortfolio

Summary

To compare the efficacy in terms of progression free survival (PFS) of the addition of cetuximab to FOLFIRI versus FOLFIRI alone given as first line therapy in patients with advanced colorectal cancer (CRC). In particular, the predictive value of PTEN mutation will be assessed in determining the effect of cetuximab+FOLFIRI as compared to chemotherapy alone.

Description

The study is an Italian, multicentre, open label, randomized trial on efficacy of first line therapies in patients with advanced CRC and KRAS wild-type, defined by molecular evaluation.

Patients will be randomized to 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

- FOLFIRI alone, 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 until disease progression or unacceptable toxicity developed. Allocation to treatment will be centrally performed with 1:1 ratio using a biased-coin minimization procedure having centre, number of organs involved (1-2 vs. more than 2) and prior neo-adjuvant or adjuvant therapy (yes vs. no), as stratification variables. Access to random system will be allowed via web. Both efficacy and safety data will be collected. The investigators will assess response to treatment every 12 weeks based on imaging. Analysis of costs and quality of life will be performed. Following permanent treatment cessation, patients will be followed-up for survival. Patients with histologically documented metastatic wild- type CRC not suitable for curative-intent resection.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Colorectal Cancer

Intervention

Cetuximab, FOLFIRI

Location

Ospedale Pesenti Fenaroli - Alzano L. - Alzano Lombardo
Alzano Lombardo
Bergamo
Italy
24022

Status

Active, not recruiting

Source

Regione Lombardia

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:55-0400

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Medical and Biotech [MESH] Definitions

Tumors or cancer of the COLON or the RECTUM or both. Risk factors for colorectal cancer include chronic ULCERATIVE COLITIS; FAMILIAL POLYPOSIS COLI; exposure to ASBESTOS; and irradiation of the CERVIX UTERI.

Tumor suppressor genes located in the 5q21 region on the long arm of human chromosome 5. The mutation of these genes is associated with the formation of colorectal cancer (MCC stands for mutated in colorectal cancer).

Tumor suppressor genes located in the 18q21-qter region of human chromosome 18. The absence of these genes is associated with the formation of colorectal cancer (DCC stands for deleted in colorectal cancer). The products of these genes show significant homology to neural cell adhesion molecules and other related cell surface glycoproteins.

A group of autosomal-dominant inherited diseases in which COLON CANCER arises in discrete adenomas. Unlike FAMILIAL POLYPOSIS COLI with hundreds of polyps, hereditary nonpolyposis colorectal neoplasms occur much later, in the fourth and fifth decades. HNPCC has been associated with germline mutations in mismatch repair (MMR) genes. It has been subdivided into Lynch syndrome I or site-specific colonic cancer, and LYNCH SYNDROME II which includes extracolonic cancer.

Nuclear phosphoprotein encoded by the p53 gene (GENES, P53) whose normal function is to control CELL PROLIFERATION and APOPTOSIS. A mutant or absent p53 protein has been found in LEUKEMIA; OSTEOSARCOMA; LUNG CANCER; and COLORECTAL CANCER.

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