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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON28016

Enrollment

Registered

2012-04-12

Start date

2011-08-05

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DPD deficiency Pharmacokinetics colorectal DPD deficiëntie kinetiek uracil colorectaal

Interventions

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

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 criteria

Exclusion criteria: 1. 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).

Design outcomes

Primary

Measure	Time frame
Compare the AUC of uracil in patients with metastatic colorectal disease and patients with adjuvant treatment.	—

Secondary

Measure	Time frame
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 mehthod and venapunction.AUC of uracil.	—

Contacts

Public ContactM. Staveren, van

Leveste Scheper Ziekenhuis Boermarkeweg 60

m.vanstaveren@sze.nl+31 (0)591 691015

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)