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Pharmacokinetics and Metabolic Activation of Capecitabine

Primary Purpose

Metastatic Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
blood samples
Sponsored by
Arbeitsgemeinschaft medikamentoese Tumortherapie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metastatic Colorectal Cancer focused on measuring colorectal carcinoma, K-ras wild type, Capecitabine, Cetuximab, Oxaliplatin, Pharmacokinetics, exclude a possible influence of CETUX, plasma disposition, metabolic activation, CCB, OxPt

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • PMU Salzburg
  • AKH Wien
  • Kaiser Franz Josef Spital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

A

B

Arm Description

Capecitabine in week 1,2,4,5,7 and 8 Cetuximab in week 3 to 9 Oxaliplatin in week 7

Capecitabine in weeks 1,2,4,5,7, and 8 Cetuximab in weeks 1,8 and 9 Oxaliplatin in week 7

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 29, 2012
Last Updated
March 6, 2015
Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
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1. Study Identification

Unique Protocol Identification Number
NCT01579357
Brief Title
Pharmacokinetics and Metabolic Activation of Capecitabine
Official Title
Pharmacokinetics and Metabolic Activation of Capecitabine When Given Concomitantly With Oxaliplatin and the Monoclonal Antibody Cetuximab
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
colorectal carcinoma, K-ras wild type, Capecitabine, Cetuximab, Oxaliplatin, Pharmacokinetics, exclude a possible influence of CETUX, plasma disposition, metabolic activation, CCB, OxPt

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Other
Arm Description
Capecitabine in week 1,2,4,5,7 and 8 Cetuximab in week 3 to 9 Oxaliplatin in week 7
Arm Title
B
Arm Type
Other
Arm Description
Capecitabine in weeks 1,2,4,5,7, and 8 Cetuximab in weeks 1,8 and 9 Oxaliplatin in week 7
Intervention Type
Other
Intervention Name(s)
blood samples
Intervention Description
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
Primary Outcome Measure Information:
Title
Influence of Cetuximab on metabolic activation of Capecitabine
Description
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.
Time Frame
9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
PMU Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
AKH Wien
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Kaiser Franz Josef Spital
City
Vienna
ZIP/Postal Code
1100
Country
Austria

12. IPD Sharing Statement

Links:
URL
http://www.agmt.at
Description
Sponsor

Learn more about this trial

Pharmacokinetics and Metabolic Activation of Capecitabine

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