ClinicalTrials.gov processed this data on March 28, 2024Link to the current ClinicalTrials.gov record.https://clinicaltrials.gov/ct2/show/NCT00422773TUD-COFI-014NCT00422773Safety of Cetuximab and Oxaliplatin/5-FU/FA/Irinotecan in First-Line Treatment of Metastatic Colorectal CancerOpen 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 CancerTechnische Universität DresdenOther
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) as first-line treatment for metastatic colorectal cancer.
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
the three patients at a dose level experience a dose-limiting toxicity (DLT) during the first
six weeks. If one of the three patients has a DLT, an additional three patients will be
enrolled at this dose level and the dose will be escalated if no additional patients
experience a DLT. Otherwise, the dose escalation will be stopped, and the last dose will be
regarded as the maximum tolerated dose (MTD). An intra-individual dose escalation is not
planned.
Expanded cohort:
The MTD cohort will be expanded to a total of 16 patients.
CompletedJanuary 2007June 2008Phase 1/Phase 2InterventionalNoNon-RandomizedSingle Group AssignmentTreatmentNone (Open Label)To assess a maximal tolerable dose and the safety of a chemotherapy-combination of cetuximab, irinotecan, oxaliplatin and 5-FU/folinic acid as first-line treatment for metastatic colorectal cancerTo assess the treatment regarding the following: feasibility, toxicity, response rate, resection rate, progression free and overall survival121Metastatic Colorectal CancerCetuximab+ FOLFOXIRIExperimentalCetuximab and Irinotecan, Oxaliplatin, 5FU and Folinic acidDrugCetuximabDose level Infusion time (h) Dose level unit 1 2 3 4 Cetuximab 2.0 mg/m² 500 500 500 500 Irinotecan, before oxaliplatin 1.0 mg/m² 95 125 165 180 Oxaliplatin, with folinic acid 2.0 mg/m² 85 85 85 85 Folinic acid, with folinic acid 2.0 mg/m² 400 400 400 400 5-FU Infusion 46.0 mg/m² 3200 3200 3200 3200Cetuximab+ FOLFOXIRICetuximab (C225, Erbitux by Merck)
Inclusion Criteria:
- 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 Criteria:
- 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
All18 YearsN/ANoGunnar Folprecht, Dr.Principal InvestigatorUniversity Hospital Dresden, Medical Department IUniversitaetsklinikum Carl Gustav Carus, Medizinische KlinikDresdenSachsen01307GermanyWestdeutsches Tumorzentrum, Universitaetsklinikum EssenEssen45112GermanyUniversitaetsklinik Mannheim GmbH, III. Medizinische KlinikMannheim68167GermanyGermanyFebruary 2009January 15, 2007January 15, 2007January 17, 2007February 26, 2009February 26, 2009February 27, 2009Gunnar FolprechtUniversity Hospital Dresden, Medical Department Iphase I/IIcetuximaboxaliplatinirinotecan5-FUchemotherapydose escalationsafetyColorectal NeoplasmsCetuximab