Patients with metastatic colorectal cancer MedDRA version: 9.1 Level: LLT Classification code 10061451 Term: Colorectal cancer
Conditions
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histology and staging disease: • Histological proven adenocarcinoma of the colon or rectum • At least one measurable metastatic lesion according to RECIST criteria • If only one metastatic lesion, histology is mandatory Mutation level: • Tumor tissue (primary or metastasis) typological classified as K-RAS wildtype in codon 12 and 13 in exon 1 at real-time PCR General conditions: • Age >18 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Prior therapy: • Prior chemotherapy for advanced/metastatic disease • Adjuvant chemotherapy must have ended > 6 months before inclusion • Prior treatment with Eloxatin • Prior treatment with Erbitux or other treatment to EGFR Prior or current history: • Current indication for resection with a curative intent • Evidence of CNS metastasis • Current infection, unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis • Current history of chronic diarrhoea • Peripheral neuropathy • Other serious illness or medical conditions (including contraindication to 5 FU e.g.: angor, myocardial infarction within 6 months, contraindications to monoclonal antibodies) • Past or concurrent history of malignant neoplasm other than colorectal adenocarcinoma within the past five years, except curatively treated non melanoma skin cancer or in situ carcinoma of the cervix Concomitant treatments: • Concomitant (or within 4 weeks before randomisation) administration of any other experimental drug under investigation • Concurrent treatment with any other anti-cancer therapy Other: • Pregnant or breast feeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective to the trial is response rate. ;Secondary Objective: The secondary objectives of the trial is to evaluate and determine progressionfree survival, time to failure of treatment strategy, survival, safety and toxicity and secundary surgical curative resection frequency. Further we will determine possible prognostic and predictive factors from tissues and bloodsamples.;Primary end point(s): Primary endpoint is to evaluate response rate. Secondary endpoints are to evaluate and determine progressionfree survival, time to failure of treatment strategy, survival, safety and toxicity and secondary surgical curative resection frequency. Further we will determine possible prognostic and predictive factors from tissues and bloodsamples. | — |
Countries
Denmark, Sweden
Outcome results
None listed