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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Colorectal Cancer

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Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Influence of Cetuximab on metabolic activation of Capecitabine

Outcome 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.

Outcome Time Frame:

9 weeks

Safety Issue:

No

Authority:

Austria: Agency for Health and Food Safety

Study ID:

AGMT-Capecet_PK

NCT ID:

NCT01579357

Start Date:

February 2012

Completion Date:

Related Keywords:

  • Metastatic Colorectal Cancer
  • colorectal carcinoma
  • K-ras wild type
  • Capecitabine
  • Cetuximab
  • Oxaliplatin
  • Pharmacokinetics
  • exclude a possible influence of CETUX
  • plasma disposition
  • metabolic activation
  • CCB
  • OxPt
  • Colorectal Neoplasms

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