Colon cancer colorectalcarcinoma
Conditions
Interventions
None listed
Sponsors
Catharina-ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Pathologically confirmed malignancy for which treatment with 5-FU is indicated in the FOLFOX, FOLFIRI or FOLFIRINOX regimen. 2) Minimal acceptable safety laboratory values defined as a. ANC of * 1.5 x 109 /L b. Platelet count of * 100 x 109 /L c. Hepatic function as defined by serum bilirubin * 1.5 x ULN, ALAT and ASAT * 2.5 x ULN; in case of liver metastases ALAT and ASAT * 5 x ULN. d. renal function as defined by MDRD >30 ml/min
Exclusion criteria
Exclusion criteria: 1. Patients with known substance abuse, psychotic disorders, and/or other diseases expected to interfere with study or the patient*s safety 2. Women who are pregnant or breast feeding 3. Patients in whom the bolus injection will be skipped due to e.g. toxicity of previous chemo therapy regimen.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| - Ratios of DHU/U, DHT/T and DHFU/FU will be calculated by using the plasma concentration - Determine DPYD genotype for each patient. If applicable, additional SNP analysis within the DPYD gene will be conducted at study end - DPD enzym activity - Severe adverse events following 5-FU infusion, including: * Toxicity-related hospitalization * Change in dose intensity: prolonged interval or dose reduction * Myelosuppression (leukocytes, neutrophils and thrombocytes) grade *3 according to CTC-AE criteria * Other toxicities including grade *3 mucositis and diarrhoea according to the CTC-AE criteria | — |
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study are the plasma concentrations of 5-FU, DHFU and endogenous biomarkers U, DHU, T and DHT at all time points by using LC-MS/MS. | — |
Countries
Netherlands
Outcome results
None listed