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Pharmacokinetics and Metabolic Activation of Capecitabine

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier:
NCT01579357
First received: March 29, 2012
Last updated: November 3, 2014
Last verified: April 2012
  Purpose

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 Intervention Phase
Metastatic Colorectal Cancer
Other: blood samples
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Pharmacokinetics and Metabolic Activation of Capecitabine When Given Concomitantly With Oxaliplatin and the Monoclonal Antibody Cetuximab

Resource links provided by NLM:


Further study details as provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:

Primary Outcome Measures:
  • Influence of Cetuximab on metabolic activation of Capecitabine [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 24
Study Start Date: February 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier: NCT01579357     History of Changes
Other Study ID Numbers: AGMT-Capecet_PK
Study First Received: March 29, 2012
Last Updated: November 3, 2014
Health Authority: Austria: Agency for Health and Food Safety

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
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Capecitabine
Cetuximab
Oxaliplatin
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014