NCT01579357

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2012

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2012

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 18, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 9, 2015

Status Verified

March 1, 2015

Enrollment Period

2.8 years

First QC Date

March 29, 2012

Last Update Submit

March 6, 2015

Conditions

Metastatic Colorectal Cancer

Keywords

colorectal carcinomaK-ras wild typeCapecitabineCetuximabOxaliplatinPharmacokineticsexclude a possible influence of CETUXplasma dispositionmetabolic activationCCBOxPt

Outcome Measures

Primary Outcomes (1)

  • 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.

    9 weeks

Study Arms (2)

A

OTHER

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

Other: blood samples

B

OTHER

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

Other: blood samples

Interventions

blood samplesOTHER

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

AB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • signed written informed consent
  • male or female \> 18 years
  • K-ras wild type adenocarcinoma of the colon or rectum
  • metastatic colorectal carcinoma
  • ECOG \<= 2

You may not qualify if:

  • brain metastasis
  • previous chemotherapy
  • stage 3 or 4 heart failure
  • uncontrolled angina
  • pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

PMU Salzburg

Salzburg, Salzburg, 5020, Austria

Location

AKH Wien

Vienna, Vienna, 1090, Austria

Location

Kaiser Franz Josef Spital

Vienna, Vienna, 1100, Austria

Location

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2012

First Posted

April 18, 2012

Study Start

February 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 9, 2015

Record last verified: 2015-03

Locations

AU(3)