PHARMACOKINETIC PERSPECTIVE STUDY IN COLORECTAL CANCER PATIENTS AND CANDIDATE FOR FLUOROPYRIMIDINE THERAPY: 5-FLUORO TEST

Primary objectives: - To evaluate 5-FU e 5-FDHU pharmacokinetic parameters after a test-dose administration (5-FU 250 mg/mq ev. bolus)
- To analyse possible correlations between pharmacokinetic results and adjuvant or first line treatment tolerability in colorectal cancer patients
- To exclude from fluoropyrimidine therapy patients with significant alterations of 5-FU and 5-FDHU pharmacokinetics (CL<1 l/h/mq, T1/2β>5 h, and Cmax<0.1 µg/ml, Tmax>60 min, respectively) after the administration of the 5-FU test-dose
Primary endpoints: - HPLC measurements of 5-FU and 5-FDHU plasma concentrations and calculation of the main pharmacokinetic parameters with the software WinNonlin 5.1 (Pharsight Corporation, USA).
- Toxicity data collection and univariate/multivariate statistical analysis of the kinetics results.
- Pharmacokinetic analysis and comparison of the results of single patients with the population previously published [Bocci et al. 2006].