1stline Study Capecitabine Administered on Continuous Way Plus Oxaliplatin&Bevacizumab Every 2weeks in Metastatic CCR.
The purpose of this study is to determinate progression free survival after 9 months of treatment.
Metastatic Colorectal Cancer
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of First Line Capecitabine Administered on Continuous Way Combined With Oxaliplatin and Bevacizumab Every Two Weeks in Metastatic Colorectal Cancer Patients.|
- Progression Free Survival [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- Overall Response rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Toxicity of the combination of capecitabine+oxaliplatin+bevacizumab [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- Resection rate of hepatic or pulmonary metastases [ Time Frame: 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2006|
|Study Completion Date:||January 2011|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
To look for a new chemotherapy management to get less acute and chronic toxicity and/or an easier administration treatment line.
This study tries to demonstrate an alternative chemotherapy scheme,continuous polychemotherapy regimen with less dose with the added effect of the monoclonal antibody Bevacizumab.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00345696
|Hospital 12 de Octubre|
|Madrid, Spain, 28041|
|Study Chair:||Cristina Grávalos, MD||Unidad Integral de Investigación en Oncología S.L.|
|Principal Investigator:||Cristina Grávalos, MD||Hospital 12 de Octubre|