Status:
COMPLETED
Safety of Cetuximab and Oxaliplatin/5-FU/FA/Irinotecan in First-Line Treatment of Metastatic Colorectal Cancer
Lead Sponsor:
Technische Universität Dresden
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to assess a maximal tolerable dose and to assess the safety of a chemotherapy-combination of cetuximab, irinotecan, oxaliplatin and 5-fluorouracil (5-FU)/folinic acid (FA)...
Detailed Description
Dose escalation: The first three patients will receive chemotherapy at the dose level 1 for 6 weeks (first three cycles). The dose will be escalated for the next patients by one dose level if none of...
Eligibility Criteria
Inclusion
- Diagnosis of non-resectable, histologically confirmed, epithelial growth factor receptor(EGFR)-positive or negative colorectal cancer
- WHO Performance status 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: neutrophil blood cell count (NBC) ≥ 1.5 x 10\^9/L, platelet count ≥ 100 x 10\^9/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.
Exclusion
- Previous exposure to epidermal growth factor receptor-targeting therapy
- Previous chemotherapy for colorectal cancer except for 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 (Common Toxicity Criteria)grade I
- Inflammatory bowel disease
- Previous malignancy (except for 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 treatment
- Pregnancy (absence to be confirmed by b-hCG (pregnancy-) 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00422773
Start Date
January 1 2007
Last Update
February 27 2009
Active Locations (3)
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1
Universitaetsklinikum Carl Gustav Carus, Medizinische Klinik
Dresden, Saxony, Germany, 01307
2
Westdeutsches Tumorzentrum, Universitaetsklinikum Essen
Essen, Germany, 45112
3
Universitaetsklinik Mannheim GmbH, III. Medizinische Klinik
Mannheim, Germany, 68167