Histologically proven metastatic colorectal cancer with k-ras wildtyp status MedDRA version: 16.1 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
University of Duisburg-Essen
Eligibility
Sex/Gender
All
Inclusion 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) • 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) • ASAT and 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 • Oxaliplatin-based adjuvant chemotherapy within 1 year before registration • Neuropathy = grade 3 (NCI_CTC V3.0) during prior oxaliplatin-based chemotherapy • 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 grade 1 • Significant disease which, in the investigator’s opinion, would exclude the patient from the study • legal incapacity or limited legal capacity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Response rate (RECIST-Criteria);Secondary Objective: • Safety • Progression-free survival time • Overall survival time • Resectability rate • Quality of life;Primary end point(s): Therapy will be continued till progress occurs. | — |
Countries
Germany
Outcome results
None listed