A Phase 2 interventional study of Bevacizumab and Capecitabine in Metastatic Colorectal Cancer, sponsored by Unidad Integral de Investigación en Oncología S.L.. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-08-24.
Sponsored by Unidad Integral de Investigación en Oncología S.L. · Phase 2, Interventional, and Treatment
The purpose of this study is to determinate progression free survival after 9 months of treatment.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 32 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →This is the only study on the registry with Unidad Integral de Investigación en Oncología S.L. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Absolute neutrophils count (ANC) \< 1.5 x 109/l. Platelet count \< 100 x 109/l. Hemoglobin \< 9 g/dl. INR > 1.5. Total bilirubin > 1.5 ULN. ALT and/or AST > 2.5 x ULN or > 5 x ULN (in case of hepatic metastasis). Alkaline phosphatase > 2.5 x ULN or >5 x ULN (in case of hepatic metastasis), or > 10 x ULN (in case of bone metastasis).
5 mg/Kg intravenous, 90-60-30 minutes, every 2 weeks.
Also known as: Avastin
600 mg/m2, orally, every 12 hours, continuous.
Also known as: Xeloda
85 mg/m2, intravenous, 2 hours infusion, every 2 weeks
Also known as: Eloxatin
Progression Free Survival
Time frame: 9 months
Overall Response rate
Time frame: 24 months
Overall survival
Time frame: 24 months
Toxicity of the combination of capecitabine+oxaliplatin+bevacizumab
Time frame: 24 months
Resection rate of hepatic or pulmonary metastases
Time frame: 24 months
This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.
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