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

Technische Universität Dresden

Status and phase

Completed

Phase 2

Phase 1

Conditions

Metastatic Colorectal Cancer

Treatments

Drug: Cetuximab

Study type

Interventional

Funder types

Other

Identifiers

NCT00422773

TUD-COFI-014

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

21 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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