A Phase II Study Alternating Erlotinib With Second-line mFOLFOX6 or FOLFIRI for Metastatic Colorectal Cancer

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

Research output: Contribution to journalArticle

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 1 2019

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irinotecan
Colorectal Neoplasms
oxaliplatin
Neutropenia
Combination Drug Therapy
Sample Size
Therapeutics
Safety
Drug Therapy
Erlotinib Hydrochloride

Keywords

  • 5-fluorouracil
  • 5-FU
  • colorectal cancer
  • EGFR
  • epidermal growth factor receptor
  • Erlotinib
  • irinotecan
  • oxaliplatin

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

A Phase II Study Alternating Erlotinib With Second-line mFOLFOX6 or FOLFIRI for Metastatic Colorectal Cancer. / Kearney, Matthew R.; Chen, Emerson Y.; Vaccaro, Gina; Strother, John; Burt, Andrea; Todd, Kendra; Donovan, Jeff; Kampa-Schittenhelm, Kerstin M.; Lopez, Charles.

In: Anticancer Research, Vol. 39, No. 1, 01.01.2019, p. 245-252.

Research output: Contribution to journalArticle

Kearney, MR, Chen, EY, Vaccaro, G, Strother, J, Burt, A, Todd, K, Donovan, J, Kampa-Schittenhelm, KM & Lopez, C 2019, 'A Phase II Study Alternating Erlotinib With Second-line mFOLFOX6 or FOLFIRI for Metastatic Colorectal Cancer' Anticancer Research, vol. 39, no. 1, pp. 245-252. https://doi.org/10.21873/anticanres.13104
Kearney, Matthew R. ; Chen, Emerson Y. ; Vaccaro, Gina ; Strother, John ; Burt, Andrea ; Todd, Kendra ; Donovan, Jeff ; Kampa-Schittenhelm, Kerstin M. ; Lopez, Charles. / A Phase II Study Alternating Erlotinib With Second-line mFOLFOX6 or FOLFIRI for Metastatic Colorectal Cancer. In: Anticancer Research. 2019 ; Vol. 39, No. 1. pp. 245-252.
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