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ACTIVE NOT RECRUITING
NCT01531595
PHASE2

Study of Bevacizumab in Combination with Alternating XELIRI and XELOX in Metastatic Colorectal Cancer

Sponsor: Pia Osterlund

View on ClinicalTrials.gov

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

Interventions

DRUG

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