Bi-weekly Cetuximab combined with FOLFOX-6 as first-line treatment in metastatic colorectal cancer patients with wild-type k-ras status - CEBIFOX

Phase 1

• Conditions: Histologically proven metastatic colorectal cancer with k-ras wildtyp status; MedDRA version: 16.1Level: PTClassification code 10061451Term: Colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2007-000460-24-DE
• Lead Sponsor: niversity of Duisburg-Essen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-21
• Last Update Posted: 31 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Histologically proven metastatic colorectal cancer
• Molecular test showing no mutation in the k-ras gene of colorectal carcinoma cells
• male and female subjects = 18 years of age
• 1st occurrence of metastatic disease (not curatively resectable)
• life expectancy = 12 weeks
• presence of at least 1 bi-dimensionally measurable index lesion (not in an irradiated area)
• ECOG performance status = 2 at study entry
• Adequate bone marrow reserve:
leucocytes = 3.0 x 109/l with neutrophils = 1.5 x 109/l,
platelets = 100 x 109/l, haemoglobin = 6.21 mmol/l (10 g/dl)
• ASAT and ALAT = 2.5 x upper reference range, in case of liver metastasis = 5 x upper reference range
• Serum creatinine = 1.5 x upper reference range
• Bilirubin = 1.5 x upper reference range
• Negative pregnancy test for female and effective contraception for both male and female subjects if the risk of conception exists
• signed written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Evidence for a mutation of the k-ras gene in the colorectal carcinoma cells
• previous exposure to epidermal growth factor receptor-targeting therapy
• prior chemotherapy for metastatic disease
• Oxaliplatin-based adjuvant chemotherapy within 1 year before registration
• Neuropathy = grade 3 (NCI_CTC V3.0) during prior oxaliplatin-based chemotherapy
• Other previous malignancy with exception of a history of a previous curatively treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
• Radiotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug in the 30 days before registration
• Concurrent chronic systemic immune therapy or hormone therapy not indicated in this study protocol
• Creatinine clearance < 30 ml/min
• Known hypersensitivity reaction to any of the components of study treatment
• pregnancy (absence to be confirmed by ß-hCG test) or lactation period
• Clinically relevant coronary artery disease, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia
• Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
• Brain metastasis (known or suspected)
• Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent
• Known alcohol or drug abuse
• Participation in another clinical study within the 30 days before registration
• peripheral neuropathy > grade 1
• Significant disease which, in the investigator’s opinion, would exclude the patient from the study
• legal incapacity or limited legal capacity

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Response rate (RECIST-Criteria);Secondary Objective: • Safety<br>• Progression-free survival time<br>• Overall survival time<br>• Resectability rate<br>• Quality of life;Primary end point(s): Therapy will be continued till progress occurs.