Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Per Pfeiffer
With
Odense University Hospital
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 \< 75 years
WHO performance status ≤ 2; life expectancy of more than 3 months
Adequate haematological function: (Hb ≥ 6.2 μmol/d, ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L)
Adequate renal and hepatic functions: total bilirubin ≤ 1.5 upper normal limit, creatinine ≤ 1.25 × upper normal limit, ALAT ≤ 3 x upper normal limits, and ≤ 5 x upper normal limits in case of liver metastases
Written informed consent prior to randomisation must be obtained and documented according to the local regulatory requirements
Other:
Fertile patients must use adequate contraceptives
You may not be if
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 diarrhea
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
Clareo Health | FLOX + Cetuximab (Erbitux®) for Patients With Metastatic Colorectal Cancer and Wild Type K-RAS Tumor
