Colo-rectal adenocarcinoma. MedDRA version: 9.1 Level: LLT Classification code 10061451 Term: Colorectal cancer
Conditions
Interventions
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Fluorouracil
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Sponsors
AZIENDA OSPEDALIERA PISANA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histological diagnosis of colon or rectum adenocarcinoma. - Life expectation longer than 6 months. - Proper renal functionality. - Proper hepatic functionality. - Proper medullary functionality. - Radiotherapy or surgery performed since over 4 weeks. - Patients candidate for adjuvant therapy with fluoropyrimidines alone or combined with other chemotherapeutics (oxaliplatin, irinotecan). - Patients candidate for first line therapy with fluoropyrimidines combined with oxaliplatin and/or irinotecan and/or bevacizumab. - Written informed consent. 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: - Pregnancy or breast-feeding. - Crohn?s disease, ulcerous colitis or other intestinal inflammatory diseases. - Total colectomy or ileostomy. - Intestinal occlusion or subocclusion. - Metabolic diseases or infections. - Cardiac arrhythmia or ischemic cardiopathy not controlled. - Acute myocardial infarction in the last 2 years. - Impossibility of carrying out a suitable follow up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - 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 (CL5 h, and Cmax60 min, respectively) after the administration of the 5-FU test-dose;Secondary Objective: - To identify some pharmacokinetic parameters as toxicity indicators;Primary end point(s): - 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]. | — |
Countries
Italy
Outcome results
None listed