Advertisement

Topics

Bi-weekly Cetuximab Combined With FOLFOX-6 in Metastatic Colorectal Cancer - CEBIFOX

2014-08-27 03:16:34 | BioPortfolio

Summary

Cetuximab is normally given as a weekly schedule in the therapy of patients with metastatic colorectal cancer.

In order to improve the convenience for the patients in first line-therapy this study will evaluate the efficacy and safety of a bi-weekly combination of cetuximab with FOLFOX.

Description

For years the effective treatment of advanced CRC was limited to 5-FU. Combination of 5-FU or a 5-FU analog with oxaliplatin, which has some antitumor activity as a single agent, shows synergistic activity. Combining oxaliplatin with a twice monthly folinic acid/5-FU schedule leads to a further improvement in first-line treatment of advanced CRC thus emerging to a standard regimen in first-line therapy of mCRC.

Cetuximab is normally given as a weekly schedule. As recently shown a biweekly schedule with 500 mg/m² instead of the weekly standard regimen (initial dose of 400 mg/m² followed by 250 mg/m² every week) exhibits similar pharmacokinetic results with a comparable efficacy.

In order to improve the convenience for the patients, this study will evaluate the efficacy and safety of a bi-weekly combination of cetuximab with FOLFOX. Out of the various FOLFOX regimens the most convenient FOLFOX-6 schedule is chosen for the study, which has been tested before in two studies in combination with the standard weekly schedule of cetuximab. Recent data suggest a decreased efficacy of cetuximab in patients bearing a k-ras mutation in their CRC. Therefore only patients with no evidence for a mutated k-ras gene in the colorectal carcinoma cells will be included in this study.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Metastatic Colorectal Cancer

Intervention

Cetuximab

Location

University of Duisburg-Essen Medical School
Essen
Nordrhein-Westfalen
Germany
45122

Status

Recruiting

Source

Univeristat Duisburg-Essen

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:34-0400

Clinical Trials [4303 Associated Clinical Trials listed on BioPortfolio]

The Emergence of RAS Mutations in Metastatic Colorectal Cancer Patients Receiving Cetuximab Treatment

To evaluate the emergence of RAS mutation in patients with metastatic colorectal cancer, circulating free DNA will be analyzed using mass spectrometric genotyping in subjects during cetuxi...

Cap/Iri Plus Cetuximab Compared to Cap/ox Plus Cetuximab in Patients With Metastatic Colorectal Cancer.

A randomized phase II-study to evaluate the safety and efficacy of capecitabine plus irinotecan plus cetuximab compared to capecitabine plus oxaliplatin plus cetuximab in first-line treatm...

Phase II Study to Evaluate Safety and Efficacy of Cetuximab in Combination With XELOX for 12 Weeks Followed by Maintenance Treatment With Cetuximab Plus Capecitabine as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer.

The purpose of this study is to determine confirmed objective response rate to combination therapy with cetuximab plus XELOX for 4 cycles followed by maintenance treatment with cetuximab p...

ARQ 197 in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer

ARQ 197 or placebo in combination with irinotecan and cetuximab in patients with metastatic colorectal cancer (CRC), in subjects with wild-type KRAS alleles who have failed front-line syst...

Temsirolimus (CCI-770, Torisel) Combined With Cetuximab in Cetuximab-Refractory Colorectal Cancer

In this study, the investigational drug, temsirolimus, will be combined with cetuximab, a biologic agent used in the treatment of colorectal cancer. Cetuximab in combination with temsirol...

PubMed Articles [14169 Associated PubMed Articles listed on BioPortfolio]

Surgical treatment options following chemotherapy plus cetuximab or bevacizumab in metastatic colorectal cancer-central evaluation of FIRE-3.

The FIRE-3 trial investigated combination chemotherapy plus either cetuximab or bevacizumab in patients with untreated metastatic colorectal cancer (mCRC) not scheduled for upfront surgery. We aimed t...

Efficacy and safety of cetuximab plus FOLFOX in second-line and third-line therapy in metastatic colorectal cancer.

To evaluate the efficacy and adverse events with cetuximab plus FOLFOX administered as second- and third-line therapy in metastatic colorectal cancer (mCRC) patients.

Sodium Glucose Cotransporter 2 Inhibition Combined With Cetuximab Significantly Reduced Tumor Size and Carcinoembryonic Antigen Level in Colon Cancer Metastatic to Liver.

Combination chemotherapy with Regorafenib in metastatic colorectal cancer treatment: A single center, retrospective study.

Regorafenib has been demonstrated as effective in refractory metastatic colorectal cancer. Combination use with chemotherapy has not been reported. We examined the efficacy and safety of adding chemot...

Cetuximab Enhanced the Cytotoxic Activity of Immune Cells during Treatment of Colorectal Cancer.

Cetuximab is a chimeric IgG1 monoclonal antibody which targets the extracellular domain of epidermal growth factor receptor. This antibody is widely used for colorectal cancer (CRC) treatment but its ...

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.

More From BioPortfolio on "Bi-weekly Cetuximab Combined With FOLFOX-6 in Metastatic Colorectal Cancer - CEBIFOX"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Gastroenterology
Astroesophageal Reflux Disease (GERD) Barrett's Esophagus Celiac Disease Cholesterol Crohn's Disease Gastroenterology Hepatitis Hepatology Irritable Bowel Syndrome (IBS) Pancreatitis Peptic Ulcer Disease...

Bioinformatics
Bioinformatics is the application of computer software and hardware to the management of biological data to create useful information. Computers are used to gather, store, analyze and integrate biological and genetic information which can then be applied...


Searches Linking to this Trial