Open labeled, multicenter phase I / II study evaluating the dose escalation/ safety of Cetuximab and Oxaliplatin/ 5-FU/FA/ Irinotecan as first-line treatment of metastatic colorectal cancer - COFI06
- Conditions
- first-line treatment of metastatic colorectal cancer
- Registration Number
- EUCTR2006-004065-34-DE
- Lead Sponsor
- Technical University Dresden
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
For inclusion in the study, all of the following inclusion criteria must be fulfilled:
-Diagnosis of non-resectable, histologically confirmed, EGFR positive or negative colorectal cancer
-WHO PS 0 or 1
-Signed written informed consent
-=18 years of age
-Effective contraception for both male and female subjects if the risk of conception exists
-Adequate bone marrow function: Neutrophiles blood cell count (NBC) = 1,5x109/L, platelet count = 100x109/L, hemoglobin = 5.96 mmol/L (10 g/dL)
-Adequate liver and renal function: bilirubin = 1,5 x upper normal level (UNL) and not increasing more than 25% within the last 4 weeks, ASAT and ALAT = 5 x UNL. Serum creatinine = 1.5 x UNL.
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
Subjects are not eligible for this study if any of the following exclusion criteria apply:
-Previous exposure to epidermal growth factor receptor-targeting therapy
-Previous chemotherapy for colorectal cancer except adjuvant treatment with progression of disease documented > 6 months after end of adjuvant treatment or 5-FU in combination with radiotherapy for rectal cancer
-Radiotherapy or major abdominal or thoracic surgery within the last 4 weeks before inclusion.
-Concurrent chronic systemic immune therapy, chemotherapy or hormone therapy.
-Investigational agents or participation in clinical trials within 30 days before start of the treatment in study.
-Clinically relevant coronary disease or myocardial infarction within 12 months before study entry.
-Peripheral neuropathy > CTC grade I
-Inflammatory bowel disease
-Previous malignancy (except colorectal cancer, history of basal cell carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment)
-History of severe psychiatric illness
-Drug or alcohol abuse
-Known hypersensitivity reaction to any of the components of study treatments
-Pregnancy (absence to be confirmed by b-hCG test) or lactation period
-Brain metastasis and/or leptomeningeal disease (known or suspected)
-Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary Objective<br>To assess a maximal tolerable dose of a chemotherapy-combination of Cetuximab, Irinotecan, Oxaliplatin and 5-FU/ Folinic acid as first-line treatment for metastatic colorectal cancer.<br>;Secondary Objective: Secondary Objectives<br>To assess the treatment regarding the following:<br>·feasibility<br>·toxicity<br>·response rate<br>·resection rate<br>·progression free and overall survival<br>;Primary end point(s): To assess a maximal tolerable dose of a chemotherapy-combination of Cetuximab, Irinotecan, Oxaliplatin and 5-FU/ Folinic acid as first-line treatment for metastatic colorectal cancer.
- Secondary Outcome Measures
Name Time Method