Patient with metastatic colorectal cancer.
Conditions
Interventions
Product Name: Erbitux®
Product Code: EMD271786
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cetuximab
CAS Number: 205923-56-4
Current Sponsor code: EMD271786
Other descriptive name:
Sponsors
The Nordic Colorectal Cancer Biomodulation Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histology and staging disease: • Histologically proven adenocarcinoma of the colon or rectum; • At least one measurable metastatic disease ? uni-dimensionnally measurable lesion according to RECIST criteria; • If only one metastatic lesion and no S-CEA elevation, histology is mandatory; General conditions: • Age >18 and 10g/dl, ANC >1.5 x 109/L, platelets >100 x109/L); • Adequate renal and hepatic functions: total bilirubin 6 months before inclusion; • No previous oxaliplatin Prior or current history: • No current indication for resection with a curativw intent; • No evidence of CNS metastasis; • No current infection, unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis; • No current history of chronic diarrhoea; • No peripheral neurophathy; • No other serious illness or medical conditions (including contraindication to 5 FU eg: angor, myocardial infarction within 6 months, contraindications to monoclonal antibodies); • No 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: • No concomitant (or within 4 weeks before randomization) administration of any other experimental drug under investigation; • No concurrent treatment with any other anti-cancer therapy; Other: • Not pregnant or breast feeding • Fertile patients must use adequate contraceptives • Not include patients clearly intending to withdraw from the study if not randomised in the willing arm or patients who cannot be regularly followed up for psychological, social, familial or geographic reasons. 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: See inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare time to progression, (TTP), of treatment with cetuximab in combination with the FLOX regimen given continuously (arm B) or intermittently (arm C), with TTP of the FLOX regimen alone (arm A), in first line treatment of patient with metastatic colorectal cancer. PFS is determined and compared in all patients in the three treatment arms, and separately in patients with KRAS wild type (wt) disease and KRAS mutated (mt) disease.;Secondary Objective: • To compare time to failure of strategy (TFS) in the three treatment arms, in all patients and separately in the KRAS wt and KRAS mt patients. • Response rates in the three treatment arms, in all patients and separately in the KRAS wt and KRAS mt patients. • Response duration in the three treatment arms, in all patients and separately in the KRAS wt and KRAS mt patients. • Secondary surgical curative resection frequency, in all patients and separately in the KRAS wt and KRAS mt patients. • Safety profile of the treatment arms. • Overall survival in the treatment groups, in all patients and separately in the KRAS wt and KRAS mt patients. • Quality of life in the treatment groups, in all patients and separately in the KRAS wt and KRAS mt patients. ;Primary end point(s): Time to progression | — |
Countries
Denmark, Finland, Iceland, Sweden
Outcome results
None listed