A Non Randomized Phase II Trial to Assess Efficacy and Safety of Bevacizumab, Capecitabine and Oxaliplatin as First Line Treatment for Elderly Patients With Metastatic Colorectal Adenocarcinoma, Suitable for Polychemotherapy Treatment
The efficacy will be determined by objective response rate following RECIST criteria.
In several clinical trials with Bevacizumab, there has been demonstrated that elderly
patients benefits as well as the younger of a combination therapy with chemotherapy plus
Bevacizumab, but these results have come from subgroup analyses of trials not specifically
design to test the effect of these combinations on the elderly. This clinical trial is
specific only for elderly patients and we expect to confirm the benefits demonstrated in
other clinical trials where the elderly patients were a number reduced.
This clinical trial includes 3 substudies:
- Assessment of tumor response of CRC liver metastases to treatment with Avastin in
combination with Capecitabine and Oxaliplatin as first line treatment by dynamic ultrasound
Main objective: Assess the performance of dynamic contrast ultrasonography (CEUS, Contrast
Enhanced UltraSound) with quantification of tumor perfusion in the evaluation of tumor
response of liver metastases of colorectal carcinoma to treatment with Avastin in
combination with Capecitabine and Oxaliplatin.
-Evaluation of the antiangiogenic activity of bevacizumab combined with oxaliplatin and
capecitabine in first line treatment using MDCT perfusion studies in liver metastases of
colorectal cancer in patients over 70 years.
Main objective:Determine whether the observed changes in perfusion CT studies performed at 2
weeks of starting treatment compared to baseline are significant predictors of free time to
disease progression in patients in the trial and defined as the time since the start of
treatment until objective progressive disease by RECIST criteria.
-Characterization of resistance to bevacizumab in colon cancer in elderly patients.
Main objective: To evaluate the involvement of serum markers and markers in the primary
tumor in the resistance to bevacizumab.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression Free survival
Jaime Feliu Batlle, MD
Grupo Español Multidisciplinario de Cáncer Digestivo
Spain: Spanish Agency of Medicines