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Pharmacokinetics and Metabolic Activation of Capecitabine

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ClinicalTrials.gov Identifier: NCT01579357
Recruitment Status : Completed
First Posted : April 18, 2012
Last Update Posted : March 9, 2015
Sponsor:
Information provided by (Responsible Party):
Arbeitsgemeinschaft medikamentoese Tumortherapie

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).

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Other: blood samples Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pharmacokinetics and Metabolic Activation of Capecitabine When Given Concomitantly With Oxaliplatin and the Monoclonal Antibody Cetuximab
Study Start Date : February 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01579357


Locations
Austria
PMU Salzburg
Salzburg, Austria, 5020
AKH Wien
Vienna, Austria, 1090
Kaiser Franz Josef Spital
Vienna, Austria, 1100
Sponsors and Collaborators
Arbeitsgemeinschaft medikamentoese Tumortherapie

Additional Information:
Responsible Party: Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier: NCT01579357     History of Changes
Other Study ID Numbers: AGMT-Capecet_PK
First Posted: April 18, 2012    Key Record Dates
Last Update Posted: March 9, 2015
Last Verified: March 2015

Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
colorectal carcinoma
K-ras wild type
Capecitabine
Cetuximab
Oxaliplatin
Pharmacokinetics
exclude a possible influence of CETUX
plasma disposition
metabolic activation
CCB
OxPt

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Oxaliplatin
Cetuximab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents