Trial Information

A Phase I/II Trial of a COX-2 Inhibitor, Celebrex (Celecoxib), [National Screening Committee# 719627] With Limited Field Radiation for Intermediate Prognosis Patients With Locally Advanced Non-Small Cell Lung Cancer, With Analysis of Prognostic Factors

OBJECTIVES:

- Determine the maximum tolerated dose and the recommended phase II dose of concurrent
celecoxib and limited-field radiotherapy in intermediate-prognosis patients with
locally advanced non-small cell lung cancer.

- Determine the efficacy and toxicity of this regimen in these patients.

- Determine how the predictors of mortality in the general population (i.e., comorbid
conditions, functional status, quality of life, and psychological status) influence
prognosis, toxicity, and outcomes of therapy in patients treated with this regimen.

- Correlate circulating levels of vascular endothelial growth factor (VEGF), basic
fibroblast growth factor (bFGF), and interleukin-8 (IL8) with survival in patients
treated with this regimen.

- Correlate circulating levels of interleukin-1 (IL1), interleukin-6 (IL6), and
transforming growth factor-beta (TGFB) with pulmonary toxicity in patients treated with
this regimen.

OUTLINE: This is a phase I dose-escalation study of celecoxib followed by a phase II,
multicenter study.

- Phase I: Patients receive oral celecoxib twice daily. Beginning on day 6, patients
undergo thoracic radiotherapy 5 days a week for 3-6.5 weeks . Patients continue to
receive celecoxib for up to 2 years in the absence of disease progression or
unacceptable toxicity.

- Phase II: If fewer than 3 of the first 6 patients experience dose-limiting toxicity,
then the dose of celecoxib is escalated for all patients in the study, including those
in the first cohort.

Quality of life is assessed at baseline and at 3, 6, and 12 months after start of therapy.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 6-12 patients will be accrued for the phase I portion of this
study and a total of 116 patients will be accrued for the phase II portion of this study
within 25 months.