Clinical trial · Interventional
Capecitabine Plus Oxaliplatin Plus Bevacizumab as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer
A Multicenter Phase II Study of the Capecitabine, Oxaliplatin and Bevacizumab as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer
NCT01024504CI-TRIAL-00003347completedPhase 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 trial will evaluate the efficacy and safety of the capecitabine and oxaliplatine plus bevacizumab combination as first-line treatment in elderly patients with 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- XELOX/Avastin
- description
- Capecitabine Oxaliplatin Bevacizumab
- interventionNames
- Drug: Oxaliplatin
- Drug: Capecitabine
- Drug: Bevacizumab
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- 2 - 4 months
Secondary outcomes (3)
- measure
- Toxicity profile
- timeFrame
- Toxicity assessment on each cycle
- measure
- Time to tumor progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the colon or rectum * Stage IV * Existence of two-dimensional measurable disease. The measurable disease should not have been irradiated. * Absence or irradiated and stable central nervous system metastatic disease. * Life expectancy of more than 3 months. * Age ≥ 70 years. * Performance status (WHO) ≤ 2. * Adequate bone marrow function (Absolute neutrophil count \>1000/mm3, Platelet count \>100000/mm3, Hemoglobin \>9gr/mm3). * Adequate liver (Bilirubin \<1.5 times upper limit of normal and SGOT/SGPT \<2 times upper limit of normal). * Creatinine clearance (Cockcroft-Gault formula) \>30ml/min. * No other invasive malignancy within the past 5 years except nonmelanoma skin cancer. * Presence of a reliable care giver. * Informed consent. Exclusion Criteria: * Prior chemotherapy for metastatic disease. * History of thromboembolic disease or myocardial infraction within the last 6 months. * Peripheral neuropathy ≥ grade 2. * Bowel obstruction or chronic diarrhea. * Psychiatric illness or social situation that would preclude study compliance. * Other concurrent uncontrolled illness. * Other concurrent investigational agents.
References
Publications (1)
- DERIVEDVamvakas L, Matikas A, Karampeazis A, Hatzidaki D, Kakolyris S, Christophylakis C, Boukovinas I, Polyzos A, Georgoulias V, Souglakos J. Capecitabine in combination with oxaliplatin and bevacizumab (AXELOX) as 1st line treatment for fit and vulnerable elderly patients (aged >70 years) with metastatic colorectal cancer (mCRC): a multicenter phase II study of the Hellenic Oncology Research Group (HORG). BMC Cancer. 2014 Apr 22;14:277. doi: 10.1186/1471-2407-14-277. PMID 24755296