Clinical trial · Interventional
A Study of Xeloda (Capecitabine) in Patients With Advanced and/or Metastatic Colorectal Cancer
An Open-label Study of the Effect of Intermittent Xeloda in Combination With Irinotecan on Treatment Response in Patients With Advanced and/or Metastatic Colorectal Cancer
NCT00048139CI-TRIAL-00024577completedPhase 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)
This study will assess the efficacy and safety of intermittent oral Xeloda administration in combination with irinotecan as a first-line treatment in patients with advanced and/or metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months and the target sample size is \<100 individuals.
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine [Xeloda] | Drug | Capecitabine | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: Irinotecan
- Drug: capecitabine [Xeloda]
Primary outcomes (1)
- measure
- Tumor measurement (RECIST criteria)
- timeFrame
- Event driven
Secondary outcomes (1)
- measure
- Efficacy: Time to progression, time to response, duration of response, time to treatment failure, survival.
- timeFrame
- Event driven
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * adult patients \>=18 years of age; * locally advanced and/or metastatic colorectal cancer; * \>=1 target lesion. Exclusion Criteria: * previous treatment with Xeloda or irinotecan; * previous systemic therapy for metastatic disease; * progressive disease during previous adjuvant therapy or within 6 months of completion.
References
Publications (0)
Data not yet available
No reference posted for this study.