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

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

Timeline

Start

2012-02

Primary completion

2025-12

Completion

2025-12

Publications

• Osterlund E, Ristimaki A, Makinen MJ, Kytola S, Kononen J, Pfeiffer P, Soveri LM, Keinanen M, Sorbye H, Nunes L, Salminen T, Nieminen L, Uutela A, Halonen P, Algars A, Sundstrom J, Kallio R, Ristamaki R, Lamminmaki A, Stedt H, Heerva E, Kuopio T, Sjoblom T, Isoniemi H, Glimelius B, Osterlund P. Atypical (non-V600E) BRAF mutations in metastatic colorectal cancer in population and real-world cohorts. Int J Cancer. 2024 Feb 1;154(3):488-503. doi: 10.1002/ijc.34733. Epub 2023 Sep 19.

Drugs

Indications