Pharmacokinetics and Metabolic Activation of Capecitabine
This study is currently recruiting participants.
Verified April 2012 by Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsor:
Arbeitsgemeinschaft medikamentoese Tumortherapie
Information provided by (Responsible Party):
Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier:
NCT01579357
First received: March 29, 2012
Last updated: April 17, 2012
Last verified: April 2012
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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 Primary Completion Date: | February 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01579357
Locations
| Austria | |
| PMU Salzburg | Not yet recruiting |
| Salzburg, Austria, 5020 | |
| Contact: Michaela Schachner, Mag. | |
| Principal Investigator: Richard Greil, Univ. Prof. Dr. | |
| Kaiser Franz Josef Spital | Recruiting |
| Vienna, Austria, 1100 | |
| Contact: Tanja Steininger, MSc tanja.steininger@extern.wienkav.at | |
| Principal Investigator: Christian Dittrich, Univ. Prof. Dr. | |
| AKH Wien | Not yet recruiting |
| Vienna, Austria, 1090 | |
| Contact: Eveline Holzmeier | |
| Principal Investigator: Werner Scheithauer, Univ. Prof. Dr. | |
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: | April 17, 2012 |
| 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 Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
Rectal Diseases Oxaliplatin Capecitabine Cetuximab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013