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The Pharmacokinetics of an oral uracil dose in patients with colorectal carcinoma.


- candidate number12235
- NTR NumberNTR3395
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-apr-2012
- Secondary IDsEudraCT2009-017620-11 EudraCT
- Public TitleThe Pharmacokinetics of an oral uracil dose in patients with colorectal carcinoma.
- Scientific TitleThe Pharmacokinetics of an oral uracil dose in patients with colorectal carcinoma.
- ACRONYMKINURA-2
- hypothesisDihydropyrimidine Dehydrogenase (DPD) is the initial and rate-limiting enzyme in the metabolism of 5-fluorouracil (5-FU). Patients with a partial or complete DPD deficiency are at risk to develop severe toxicity after 5-FU administration. Uracil is degraded in dihydrouracil in a similar way as 5-FU. Hypothetically, DPD deficiency may cause higher uracil levels and a reduced turnover of uracil into dihydrouracil. An oral uracil test dose might be useful to determine the systemic DPD activity by measuring uracil and its metabolite dihydrouracil in plasma.
- Healt Condition(s) or Problem(s) studiedPharmacokinetics, Colorectal, DPD deficiency
- Inclusion criteria1. Age > 18 year;
2. Metastatic disease or adjuvant treatment;
3. Signed informed consent;
4. DPD activity in PBMCs ≥ 6 nmol/mg/hr;
5. Live expectation > 3 months.
- Exclusion criteria1. DPD activity in PBMCs < 6 nmol/mg/hr;
2. Pregnancy;
3. Breasfeeding;
4. The use of Cimetidine (regarding drug interactions with 5-fluorouracil and capecitabine);
5. Reduced renal function (creatinine clearance <50 ml/min, calculated with the Cockcroft&Gault formula).
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 5-aug-2011
- planned closingdate5-aug-2012
- Target number of participants24
- InterventionsAn oral dose of 500 mg/m2 is adminstered to patients. Bloodsamples are obtained just before and on several timepoints after dosage.
- Primary outcomeCompare the AUC of uracil in patients with metastatic colorectal disease and patients with adjuvant treatment.
- Secondary outcomeThe second objective of the study is to determine if there is a interpatient correlation between uracil levels determined in blood sampled with a newly developed bloodspot mehthod and venapunction.AUC of uracil.
- Timepointst = 0, 15, 30, 45, 60, 80, 100, 120, 150, 180 en 240 minutes after intake of uracil.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. M. Staveren, van
- CONTACT for SCIENTIFIC QUERIESDrs. M. Staveren, van
- Sponsor/Initiator Leiden University Medical Center (LUMC), Leveste Scheper Ziekenhuis
- Funding
(Source(s) of Monetary or Material Support)
Leveste Scheper ziekenhuis, Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryBackground of the study:
Dihydropyrimidine Dehydrogenase (DPD) is the initial and rate-limiting enzyme in the metabolism of 5-fluorouracil (5-FU).
Patients with a partial or complete DPD deficiency are at risk to develop severe toxicity after 5-FU administration. Uracil is degraded in dihydrouracil in a similar way as 5-FU. Hypothetically, DPD deficiency may cause higher uracil levels and a reduced turnover of uracil into dihydrouracil. An oral uracil test dose might be useful to determine the systemic DPD activity by measuring uracil and its metabolite dihydrouracil in plasma.

Objective of the study:
To compare the pharmacokinetic profile of uracil in cancer patients and healthy volunteers.

Study design:
Case control PK study with 24 patients diagnosed with colorectal cancer.

Study population:
Cancer patients with or without metastasis, age > 18 jaar, DPD activity in PBMC ? 6 nmol/mg/hour treated with 5-FU or capecitabine.

Intervention:
An oral dose of 500 mg/m2 is adminstered to patients. Bloodsamples are obtained just before and on several timepoints after dosage.

Primary study parameters/outcome of the study:
AUC of uracil. The second objective of the study is to determine if there is a interpatient correlation between uracil levels determined in blood sampled with a newly developed bloodspot method and venapunction.
- Main changes (audit trail)
- RECORD12-apr-2012 - 10-mei-2012


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