Bi-weekly Cetuximab Combined With 5-fluorouracil/Leucovorin/Oxaliplatin (FOLFOX-6) in Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Cetuximab is normally given as a weekly schedule in the therapy of patients with metastatic colorectal cancer.

In order to improve the convenience for the patients in first line-therapy this study will evaluate the efficacy and safety of a bi-weekly combination of cetuximab with FOLFOX.

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

Details

• Lead Sponsor: Martin Schuler, Prof. Dr. med.
• Treatments: Cetuximab; Fluorouracil; Oxaliplatin

Criteria

Inclusion Criteria:

• Histologically proven metastatic colorectal cancer

• Molecular test showing no mutation in the k-ras gene of colorectal carcinoma cells

• Male and female subjects ≥ 18 years of age

• 1st occurrence of metastatic disease (not curatively resectable)

• Life expectancy ≥ 12 weeks

• Presence of at least 1 bi-dimensionally measurable index lesion (not in an irradiated area)

• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 at study entry

• Adequate bone marrow reserve:

leucocytes ≥ 3.0 x 109/l with neutrophils ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l, haemoglobin ≥ 6.21 mmol/l (10 g/dl)

• Aspartate-aminotransferase (ASAT) and alanine-aminotransferase (ALAT) ≤ 2.5 x upper reference range, in case of liver metastasis ≤ 5 x upper reference range

• Serum creatinine ≤ 1.5 x upper reference range

• Bilirubin ≤ 1.5 x upper reference range

• Negative pregnancy test for female and effective contraception for both male and female subjects if the risk of conception exists

• Signed written informed consent

Exclusion Criteria:

• Evidence for a mutation of the k-ras gene in the colorectal carcinoma cells

• Previous exposure to epidermal growth factor receptor-targeting therapy

• Prior chemotherapy for metastatic disease

• Prior oxaliplatin based adjuvant chemotherapy or < 6 months after end of adjuvant treatment

• Other previous malignancy with exception of a history of a previous curatively treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix

• Radiotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug in the 30 days before registration

• Concurrent chronic systemic immune therapy or hormone therapy not indicated in this study protocol

• Creatinine clearance < 30 ml/min

• Known hypersensitivity reaction to any of the components of study treatment

• Pregnancy (absence to be confirmed by ß-human chorionic gonadotropin (hCG) test) or lactation period

• Clinically relevant coronary artery disease, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia

• Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease

• Brain metastasis (known or suspected)

• Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent

• Known alcohol or drug abuse

• Participation in another clinical study within the 30 days before registration

• Peripheral neuropathy > grade 1

• Significant disease which, in the investigator's opinion, would exclude the patient from the study

• Legal incapacity or limited legal capacity