A phase II study alternating erlotinib with second-line mFOLFOX6 or FOLFIRI for metastatic colorectal cancer

Matthew R. Kearney, Emerson Y. Chen, Gina M. Vaccaro, John Strother, Andrea Burt, Kendra Todd, Jeff Donovan, Kerstin M. Kampa-Schittenhelm, Charles D. Lopez

Research output: Contribution to journalArticle

2 Scopus citations

Abstract

Background: Based on our pre-clinical data, we hypothesized that sequencing chemotherapy with erlotinib would increase the tumor response rate in patients with metastatic colorectal cancer. Patients and Methods: A phase II trial (planned n=58) using second-line therapy for metastatic colorectal cancer with either oxaliplatin-based (mFOLFOX6) or irinotecan-based (FOLFIRI) combination chemotherapy and 100 mg erlotinib daily on days 3-8 after each infusion (days 1 and 2) every 14 days. The primary endpoint was the response rate compared to the historical response rate. Results: The FOLFIRI/erlotinib arm met the pre-specified response rate criteria of at least 10% to expand accrual to the intended sample size. The trial was halted after an interim safety analysis (n=11) due to excess grade 3 neutropenia, dose reductions and treatment delays. Grade 3 or 4 neutropenia was observed in 64% of patients. The response rate was 18%. Conclusion: In second-line treatment for metastatic colorectal cancer, mFOLFOX6 or FOLFIRI with erlotinib in a sequence-dependent fashion is not feasible despite potential promising activity.

Original languageEnglish (US)
Pages (from-to)245-252
Number of pages8
JournalAnticancer research
Volume39
Issue number1
DOIs
StatePublished - Jan 2019

Keywords

  • 5-FU
  • 5-fluorouracil
  • Colorectal cancer
  • EGFR
  • Epidermal growth factor receptor
  • Erlotinib
  • Irinotecan
  • Oxaliplatin

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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  • Cite this

    Kearney, M. R., Chen, E. Y., Vaccaro, G. M., Strother, J., Burt, A., Todd, K., Donovan, J., Kampa-Schittenhelm, K. M., & Lopez, C. D. (2019). A phase II study alternating erlotinib with second-line mFOLFOX6 or FOLFIRI for metastatic colorectal cancer. Anticancer research, 39(1), 245-252. https://doi.org/10.21873/anticanres.13104