Metastatic Colorectal Cancer
Conditions
Keywords
colorectal carcinoma, K-ras wild type, Capecitabine, Cetuximab, Oxaliplatin, Pharmacokinetics, exclude a possible influence of CETUX, plasma disposition, metabolic activation, CCB, OxPt
Brief summary
The objective of this pharmacokinetic study is to exclude a possible influence of CETUX on the plasma disposition and metabolic activation of Capecitabine (CCB) and when this regimen is given combined with Oxaliplatin (OxPt).
Interventions
OTHERblood samples
Draw blood samples in week 1 (day 1 and day 5), in week 4 (day 1 and day 5) and in week 7 (day 1 and day 5). day 1: pre dose, 30,60,90,120,150,180,240,300 and 360min day 5: pre dose, 30,60,90,120min
Sponsors
Arbeitsgemeinschaft medikamentoese Tumortherapie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
selected: * signed written informed consent * male or female \> 18 years * K-ras wild type adenocarcinoma of the colon or rectum * metastatic colorectal carcinoma * ECOG \<= 2
Exclusion criteria
selected: * brain metastasis * previous chemotherapy * stage 3 or 4 heart failure * uncontrolled angina * pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Influence of Cetuximab on metabolic activation of Capecitabine | 9 weeks | Curve fitting of drug and metabolite concentrations will be performed. For pharmacokinetic modelling of CCB and metabolites, a non-compartment model for extravascular input will be used. For calculation of AUC and AUMC the linear trapezoid rule will be applied for the ascending part of the concentraion-time curve and the log-linear trapezoidal rule for the descending part of the concentration-time curve. |
Countries
Austria
Outcome results
None listed