Pharmacokinetics and Metabolic Activation of Capecitabine

Metastatic Colorectal Cancer Clinical Trial

Official title:

Pharmacokinetics and Metabolic Activation of Capecitabine When Given Concomitantly With Oxaliplatin and the Monoclonal Antibody Cetuximab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01579357
• Other study ID #: AGMT-Capecet_PK
• Status: Completed
• Phase: Phase 2
• First received: March 29, 2012
• Last updated: March 6, 2015
• Start date: February 2012
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this pharmacokinetic study is to exclude a possible influence of CETUX on the plasma disposition and metabolic activation of Capecitabine (CCB) and when this regimen is given combined with Oxaliplatin (OxPt).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria selected:

• signed written informed consent

• male or female > 18 years

• K-ras wild type adenocarcinoma of the colon or rectum

• metastatic colorectal carcinoma

• ECOG <= 2

Exclusion Criteria selected:

• brain metastasis

• previous chemotherapy

• stage 3 or 4 heart failure

• uncontrolled angina

• pregnancy or lactation

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Other:
• blood samples
Draw blood samples in week 1 (day 1 and day 5), in week 4 (day 1 and day 5) and in week 7 (day 1 and day 5). day 1: pre dose, 30,60,90,120,150,180,240,300 and 360min day 5: pre dose, 30,60,90,120min

Locations

Country	Name	City	State
Austria	PMU Salzburg	Salzburg
Austria	AKH Wien	Vienna
Austria	Kaiser Franz Josef Spital	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Arbeitsgemeinschaft medikamentoese Tumortherapie

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Influence of Cetuximab on metabolic activation of Capecitabine	Curve fitting of drug and metabolite concentrations will be performed. For pharmacokinetic modelling of CCB and metabolites, a non-compartment model for extravascular input will be used. For calculation of AUC and AUMC the linear trapezoid rule will be applied for the ascending part of the concentraion-time curve and the log-linear trapezoidal rule for the descending part of the concentration-time curve.	9 weeks

External Links

•   Sponsor