Clinical trial · Interventional
A Phase II Study of Gemcitabine and Capecitabine for Treatment Resistant, Metastatic Colorectal Cancer
NCT01472770CI-TRIAL-00016240GemCaPcompletedPhase 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 present study aims to investigate the efficacy and safety of the combination of capecitabine and gemcitabine in heavily pre-treated, treatment resistant metastatic colorectal cancer.
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 |
|---|---|---|---|
| Gemcitabine + Capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Rate of patients progression free at 3 months
- timeFrame
- 3 months after start of treatment
Secondary outcomes (2)
- measure
- Progression free survival
- timeFrame
- Every 12 weeks
- measure
- Overall survival
- timeFrame
- Every 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically verified colorectal adenocarcinomas * Age \> 18 years * Metastatic colorectal cancer refractory to 5-FU, oxaliplatin, irinotecan and relevant biological agents. * Measurable disease according to RECIST 1.1 * ECOG performance status 0, 1 or 2 * Adequate renal, hepatic and haematological function * Consent to blood samples and available paraffin embedded tumour material for translational research studies * Fertile males and females (\<2 years after last period for women) must use effective birth control. * Signed Informed consent Exclusion Criteria: * Clinically significant concurrent disease. * Other malignant diseases within 5 years of inclusion in the study, except squamous cell carcinoma of the skin and cervical carcinoma-in-situ. * Other experimental therapy within 30 days of treatment initiation. * Patients who are breast feeding, childbearing or of childbearing potential without using dual effective contraception. * Clinical or radiological evidence of CNS metastasis. * Planned radiation therapy against target-lesions. * Known allergy to 5FU/capecitabine or gemcitabine.
References
Publications (0)
Data not yet available
No reference posted for this study.