Pharmacokinetics and Metabolic Activation of Capecitabine

March 6, 2015 updated by: Arbeitsgemeinschaft medikamentoese Tumortherapie

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria, 5020
        • PMU Salzburg
      • Vienna, Austria, 1090
        • AKH Wien
      • Vienna, Austria, 1100
        • Kaiser Franz Josef Spital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: A
Capecitabine in week 1,2,4,5,7 and 8 Cetuximab in week 3 to 9 Oxaliplatin in week 7
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
Other: B
Capecitabine in weeks 1,2,4,5,7, and 8 Cetuximab in weeks 1,8 and 9 Oxaliplatin in week 7
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Influence of Cetuximab on metabolic activation of Capecitabine
Time Frame: 9 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

March 29, 2012

First Submitted That Met QC Criteria

April 17, 2012

First Posted (Estimate)

April 18, 2012

Study Record Updates

Last Update Posted (Estimate)

March 9, 2015

Last Update Submitted That Met QC Criteria

March 6, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGMT-Capecet_PK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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