Clinical trial · Interventional
First-line Therapy of Stage IV Colorectal Cancer
A Phase I/II Study of Capecitabine/Oxaliplatin (XELOX) in Combination With Bevacizumab and Imatinib as First-line Treatment of Patients With Stage IV Colorectal Cancer
NCT00784446CI-TRIAL-00008806completedPhase 1 / Phase 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)
Assessment of safety and toxicity, definition of the dose limiting toxicity (DLT) of the combination therapy consisting of Capecitabine, Oxaliplatin, Bevacizumab and Imatinib.
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 |
|---|---|---|---|
| Stage IV Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxaliplatin, Capecitabine, Bevacizumab, Imatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- NO_INTERVENTION
- label
- XELOX, Bevacizumab, Imatinib
- interventionNames
- Drug: Oxaliplatin, Capecitabine, Bevacizumab, Imatinib
Primary outcomes (1)
- measure
- Dose limiting toxicity.
- timeFrame
- 6 weeks
Secondary outcomes (1)
- measure
- Assessment of overall response rate and progression free survival.
- timeFrame
- 6 month
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven inoperable colorectal cancer * Adult patients \>= 18 years of age * ECOG \<2 Exclusion Criteria: * Preceding chemo- or immunotherapy with the exception of adjuvant or neoadjuvant treatment of non-metastatic disease ending ≥ 6 month prior to study inclusion. Progression within 6 month after the end of adjuvant therapy must be excluded. * Other malignancies with the exception of basal cell carcinoma or successfully treated carcinoma in situ of the cervix uteri. * No history of severe comorbidities, i. e. uncontrolled hypertension, GI-bleeding, congestive heart-failure NYHA class II-IV, symptomatic coronary heart disease, myocardial infarction within 1 year prior to study inclusion, serious cardiac arrhythmias requiring medication, Grade II or greater peripheral vascular disease and other severe uncontrolled co-morbidities * No history of stroke or other CNS-diseases (tumors, seizure, transient ischemic attack etc.) * ≥ Grade II peripheral artery vascular occlusive disease * Preexisting neuropathy ≥ Grade 1 * Interstitial pneumonia or lung fibrosis * Serious, nonhealing wound, ulcer, or bone fracture * Preceding irradiation an indicator lesion except for documented progressive disease during irradiation and termination of irradiation ≥ 4 weeks from study inclusion * Thromboembolic or bleeding events within the last 6 month * Need for therapeutic anticoagulation (heparin, cumarin) * Use of ASS \> 325 mg/die or NSAR * Proteinuria \> 1+ (stix) as long as urine protein \>1g/24h
References
Publications (0)
Data not yet available
No reference posted for this study.