Clinical Research Directory
Browse clinical research sites, groups, and studies.
Study of Bevacizumab in Combination with Alternating XELIRI and XELOX in Metastatic Colorectal Cancer
Sponsor: Pia Osterlund
Summary
* Open-label, single-arm, phase II study of bevacizumab (AvastinTM) in combination with alternating XELIRI (capecitabine+irinotecan) and XELOX (capecitabine+oxaliplatin) as first-line treatment of patients with metastatic colorectal cancer. * Primary objective: Progression Free Survival (PFS), * To assess overall resectability in patients with metastatic colorectal cancer, postoperative morbidity and outcomes after resection. * Secondary objectives: To assess response rates according to RECIST criteria, failure free survival (TTF) and overall survival (OS), Quality of life according to 15-dimensional instrument (15D) questionnaire, To radiologically assess tumour density and morphology, and assess alternative radiologic response evaluation in comparison with RECIST response criteria, Biomarker evaluation to measure plasma biomarkers, tumour blocks and DNA polymorphisms that may predict drug effects, safety, resectability and clinical behaviour of the tumour
Official title: Phase 2 Study of Bevacizumab in Combination with Alternating XELIRI and XELOX As First-line Treatment of Patients with Metastatic Colorectal Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2012-02
Completion Date
2025-12
Last Updated
2024-12-12
Healthy Volunteers
No
Conditions
Interventions
Bevacizumab plus alternating XELOX/XELIRI
3 cycles of XELOX+bevacizumab alternating with 3 cycles XELIRI+bevacizumab until disease progression
Locations (1)
Department of Oncology
Helsinki, Finland