Phase 1 trial of concurrent erlotinib, celecoxib, and reirradiation for recurrent head and neck cancer

Johnny Kao, Eric M. Genden, Chien Ting Chen, Michael Rivera, Charles C L Tong, Kryztof Misiukiewicz, Vishal Gupta, Vivek Gurudutt, Marita Teng, Stuart Packer

Research output: Contribution to journalArticle

47 Citations (Scopus)

Abstract

Backkground: Concurrent inhibition of epidermal growth factor receptor (EGFR) and cyclooxygenase-2 (COX-2) is an active and well tolerated regimen in recurrent head and neck cancer (HNC). In the current phase 1 trial, the authors sought to determine the maximum tolerated dose (MTD) and efficacy of concurrent erlotinib and celecoxib as a radiosensitizing regimen. Methods: Fourteen patients with previously irradiated HNC with no distant metastases who required reirradiation were eligible. Treatment consisted of daily erlotinib 150 mg and twice daily celecoxib (escalated from 200 mg to 600 mg using a 3 + 3 design with an expanded cohort at the MTD) starting on Day 1 and was continued during radiation. Daily radiation was started on Day 15, and maintenance erlotinib was recommended. Results: The recommended phase 2 dose of celecoxib was 400 mg. Three dose-limiting toxicities included late in-field orocutaneous fistula (Dose Level 2), osteonecrosis (Dose Level 3), and trismus (Dose Level 3). Acute grade ≥ 3 toxicities were uncommon and included mucositis (21%) and dermatitis (14%). At a median follow-up of 11 months, the 1-year locoregional control, progression-free survival, and overall survival rates were 60%, 37%, and 55%, respectively. Conclusions: Concurrent erlotinib, celecoxib, and reirradiation was a feasible and clinically active regimen in a population of patients with recurrent HNC who had a poor prognosis.

Original languageEnglish (US)
Pages (from-to)3173-3181
Number of pages9
JournalCancer
Volume117
Issue number14
DOIs
StatePublished - Jul 15 2011
Externally publishedYes

Fingerprint

Celecoxib
Head and Neck Neoplasms
Maximum Tolerated Dose
Trismus
Radiation
Mucositis
Osteonecrosis
Dermatitis
Cyclooxygenase 2
Epidermal Growth Factor Receptor
Disease-Free Survival
Fistula
Survival Rate
Maintenance
Neoplasm Metastasis
Erlotinib Hydrochloride
Re-Irradiation
Population

Keywords

  • celecoxib
  • cyclooxygenase-2
  • epidermal growth factor receptor
  • erlotinib
  • intensity-modulated radiotherapy
  • reirradiation

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Kao, J., Genden, E. M., Chen, C. T., Rivera, M., Tong, C. C. L., Misiukiewicz, K., ... Packer, S. (2011). Phase 1 trial of concurrent erlotinib, celecoxib, and reirradiation for recurrent head and neck cancer. Cancer, 117(14), 3173-3181. https://doi.org/10.1002/cncr.25786

Phase 1 trial of concurrent erlotinib, celecoxib, and reirradiation for recurrent head and neck cancer. / Kao, Johnny; Genden, Eric M.; Chen, Chien Ting; Rivera, Michael; Tong, Charles C L; Misiukiewicz, Kryztof; Gupta, Vishal; Gurudutt, Vivek; Teng, Marita; Packer, Stuart.

In: Cancer, Vol. 117, No. 14, 15.07.2011, p. 3173-3181.

Research output: Contribution to journalArticle

Kao, J, Genden, EM, Chen, CT, Rivera, M, Tong, CCL, Misiukiewicz, K, Gupta, V, Gurudutt, V, Teng, M & Packer, S 2011, 'Phase 1 trial of concurrent erlotinib, celecoxib, and reirradiation for recurrent head and neck cancer', Cancer, vol. 117, no. 14, pp. 3173-3181. https://doi.org/10.1002/cncr.25786
Kao J, Genden EM, Chen CT, Rivera M, Tong CCL, Misiukiewicz K et al. Phase 1 trial of concurrent erlotinib, celecoxib, and reirradiation for recurrent head and neck cancer. Cancer. 2011 Jul 15;117(14):3173-3181. https://doi.org/10.1002/cncr.25786
Kao, Johnny ; Genden, Eric M. ; Chen, Chien Ting ; Rivera, Michael ; Tong, Charles C L ; Misiukiewicz, Kryztof ; Gupta, Vishal ; Gurudutt, Vivek ; Teng, Marita ; Packer, Stuart. / Phase 1 trial of concurrent erlotinib, celecoxib, and reirradiation for recurrent head and neck cancer. In: Cancer. 2011 ; Vol. 117, No. 14. pp. 3173-3181.
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