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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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) as first-line treatment for metastatic colorectal cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Technische Universität Dresden
• Treatments: Camptothecin; Cetuximab; Irinotecan; Oxaliplatin

Criteria

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