Clinical trial · Interventional
Pharmacokinetics and Metabolic Activation of Capecitabine
Pharmacokinetics and Metabolic Activation of Capecitabine When Given Concomitantly With Oxaliplatin and the Monoclonal Antibody Cetuximab
NCT01579357CI-TRIAL-00017078completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| blood samples | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- A
- description
- Capecitabine in week 1,2,4,5,7 and 8 Cetuximab in week 3 to 9 Oxaliplatin in week 7
- interventionNames
- Other: blood samples
- type
- OTHER
- label
- B
- description
- Capecitabine in weeks 1,2,4,5,7, and 8 Cetuximab in weeks 1,8 and 9 Oxaliplatin in week 7
- interventionNames
- Other: blood samples
Primary outcomes (1)
- measure
- Influence of Cetuximab on metabolic activation of Capecitabine
- timeFrame
- 9 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.