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Safety of Cetuximab and Oxaliplatin/5-FU/FA/Irinotecan in First-Line Treatment of Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT00422773
First received: January 15, 2007
Last updated: February 26, 2009
Last verified: February 2009

January 15, 2007
February 26, 2009
January 2007
June 2008   (final data collection date for primary outcome measure)
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 cancer
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 cancer.
Complete list of historical versions of study NCT00422773 on ClinicalTrials.gov Archive Site
To assess the treatment regarding the following: feasibility, toxicity, response rate, resection rate, progression free and overall survival
To assess the treatment regarding the following:feasibility, toxicity, response rate, resection rate, progression free and overall survival
Not Provided
Not Provided
 
Safety of Cetuximab and Oxaliplatin/5-FU/FA/Irinotecan in First-Line Treatment of Metastatic Colorectal Cancer
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

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Colorectal Cancer
Drug: Cetuximab
Dose 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 3200
Other Name: Cetuximab (C225, Erbitux by Merck)
Experimental: Cetuximab+ FOLFOXIRI
Cetuximab and Irinotecan, Oxaliplatin, 5FU and Folinic acid
Intervention: Drug: Cetuximab
Folprecht G, Hamann S, Schütte K, Trarbach T, Stoehlmacher-Williams J, Ehninger G. Dose escalating study of cetuximab and 5-FU/folinic acid (FA)/oxaliplatin/irinotecan (FOLFOXIRI) in first line therapy of patients with metastatic colorectal cancer. BMC Cancer. 2014 Jul 19;14:521. doi: 10.1186/1471-2407-14-521.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
Not Provided
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00422773
TUD-COFI-014
Not Provided
Gunnar Folprecht, University Hospital Dresden, Medical Department I
Technische Universität Dresden
Not Provided
Principal Investigator: Gunnar Folprecht, Dr. University Hospital Dresden, Medical Department I
Technische Universität Dresden
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP