A phase I trial of imatinib in combination with mFOLFOX6–bevacizumab in patients with advanced colorectal cancer View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2013-02

AUTHORS

M. Michael, J. Zalcberg, P. Gibbs, L. Lipton, M. Gouillou, M. Jefford, G. McArthur, M. Copeman, K. Lynch, N. C. Tebbutt

ABSTRACT

PURPOSE: Platelet-derived growth factor receptor (PDGFR) inhibition by reducing tumoral interstitial fluid pressure might increase the efficacy of chemotherapy. Imatinib inhibits PDGFR kinase activity at therapeutically relevant doses. This phase I study aimed to assess the maximal tolerated dose (MTD) of imatinib in combination with mFOLFOX6-bevacizumab in patients with advanced colorectal cancer and to identify pharmacokinetic (PK) interactions and toxicities. METHODS: Eligible patients had measurable disease and adequate organ function. On day-14, patients commenced imatinib daily plus bevacizumab (5 mg/kg/2 weekly). Two weeks later (day 1), patients were also treated with full dose mFOLFOX6-bevacizumab for 12 cycles. Blood samples were taken for PK. DLTs defined in the first 6 weeks. Standard dose escalation of imatinib, with 3 patient cohorts: planned dose levels (DL): DL1; 400 mg, DL2; 600 mg, DL3; 800 mg daily. RESULTS: Ten patients enrolled. DL1 3 patients, DL2 7 patients. DLTs observed in 3 of 6 patients in DL2: febrile neutropenia (2); Grade 3 infection and Grade 4 neutropenia (1). Neutropenia was most frequent AEs: Grade 3/4 in >60 % of patients overall. In DL2 pts, imatinib clearance was reduced post-chemotherapy (P < 0.05). Oxaliplatin and 5FU PK unchanged by imatinib. CONCLUSIONS: MTD was imatinib 400 mg plus full dose mFOLFOX-bevacizumab. Dose escalation of imatinib limited by neutropenia. Further study is warranted as imatinib can be delivered at levels that inhibit PDGFR. More... »

PAGES

321-330

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00280-012-2009-5

DOI

http://dx.doi.org/10.1007/s00280-012-2009-5

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1035281593

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/23108698


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