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Clinical Trial
. 2013 Sep 17;109(6):1408-13.
doi: 10.1038/bjc.2013.409. Epub 2013 Aug 20.

Phase I/II trial of capecitabine and oxaliplatin in combination with bevacizumab and imatinib in patients with metastatic colorectal cancer: AIO KRK 0205

T Hoehler  1 , G von Wichert, C Schimanski, S Kanzler, M H Moehler, A Hinke, T Seufferlein, J Siebler, A Hochhaus, D Arnold, M Hallek, R Hofheinz, U T Hacker
Affiliations
Clinical Trial

Phase I/II trial of capecitabine and oxaliplatin in combination with bevacizumab and imatinib in patients with metastatic colorectal cancer: AIO KRK 0205

T Hoehler et al. Br J Cancer. .

Abstract

Background: Combined inhibition of platelet-derived growth factor receptor beta signalling and vascular endothelial growth factor promotes vascular normalisation in preclinical models and may lead to increased delivery of chemotherapy to tumour tissue. This phase I/II trial assessed the safety and efficacy of capecitabine plus oxaliplatin (XELOX) plus bevacizumab and imatinib in the first-line treatment of patients with metastatic colorectal cancer.

Methods: Two dose levels (I/II) were defined: capecitabine 850/1000 mg m(-2) twice daily on days 1-14; oxaliplatin 100/130 mg m(-2) on day 1; bevacizumab 7.5 mg kg(-1) on day 1; imatinib 300 mg day(-1) on days 1-21 every 21 days. The primary study endpoint was safety. The phase II secondary endpoint was 6-month progression-free survival (PFS).

Results: Dose level I was chosen for phase II testing because, even though further dose escalation was permitted by the protocol, gastrointestinal toxicities were considered to be clinically significant. A total of 49 patients were evaluated. The 6-month PFS rate was 76%, median PFS was 10.6 months and median overall survival was 23.2 months. Haematological toxicities were generally mild. Sensory neuropathy and diarrhoea were the most common grade 3 toxicities.

Conclusion: The combination of XELOX with bevacizumab and imatinib is tolerable and has promising efficacy.

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Figures

Figure 1
Figure 1
Probability of PFS and OS.
See this image and copyright information in PMC

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