Phase I dose escalation study of capecitabine and erlotinib concurrent with radiation in locally advanced pancreatic cancer

Yixing Jiang, Heath Mackley, Eric T. Kimchi, Junjia Zhu, Niraj J. Gusani, Jussuf Kaifi, Kevin F. Staveley-O'Carroll, Chandra Belani

Research output: Contribution to journalArticlepeer-review

7 Scopus citations

Abstract

Purpose: Pancreatic cancer is one of the leading causes of cancer-related deaths worldwide. The median survival of locally advanced nonoperable disease is approximately 9 months. 5-FU-based chemoradiotherapy has been the standard treatment. However, the survival benefit of this approach is modest. To improve the efficacy of 5-FU-based chemoradiation therapy, we evaluated the safety and feasibility of the combination of capecitabine and erlotinib with radiotherapy in this group of patients. Experimental design: A traditional "3 + 3" dose escalation design was adopted in the study. A total of four dose levels were designed. For safety purpose, a minus I dose level (-I) was also planned. The -I level consisted of capecitabine 600 mg/m2 and erlotinib 50 mg daily, and the remaining four dose levels were as follows: level I: capecitabine 600 mg/m2 bid (twice daily); level II: 700 mg/m2 bid; level III: 825 mg/m2 bid; and level IV: 925 mg/m2 bid. Erlotinib was administered at 100 mg daily at all dose levels. Erlotinib and capceitabine were given continuously Monday through Friday concurrent with radiotherapy (50.4 Gy in 28 fractions). Results: A total of 18 patients were consented. Fifteen patients were enrolled and completed therapy. No dose-limiting toxicity was observed. The most frequent side effects were lymphopenia, nausea, vomiting, diarrhea, electrolyte imbalances, and skin rashes. The majority of the toxicities were grade 1 and 2. No objective response was observed. The median progression-free survival was 0.59 years (95 % CI 0.31-1.1), and the median overall survival was 1.1 years (95 % CI 0.62-1.59). Conclusions: The combination of capecitabine and erlotinib with radiotherapy in locally advanced pancreatic cancer is well tolerated and feasible at the dose level of capecitabine 925 mg/m2 bid and erlotinib 100 mg daily.

Original languageEnglish (US)
Pages (from-to)205-210
Number of pages6
JournalCancer Chemotherapy and Pharmacology
Volume74
Issue number1
DOIs
StatePublished - Jul 2014

All Science Journal Classification (ASJC) codes

  • Oncology
  • Toxicology
  • Pharmacology
  • Cancer Research
  • Pharmacology (medical)

Fingerprint Dive into the research topics of 'Phase I dose escalation study of capecitabine and erlotinib concurrent with radiation in locally advanced pancreatic cancer'. Together they form a unique fingerprint.

Cite this