A Phase II Trial of Celecoxib Plus Chemotherapy [Docetaxel or Pemetrexed] in Patients With Previously Treated, "COX Dependent" Recurrent Non-Small Cell Lung Cancer
- To determine the efficacy of celecoxib when administered with standard chemotherapy
comprising docetaxel or pemetrexed disodium in patients with advanced, recurrent
non-small cell lung cancer (NSCLC) exhibiting cyclooxygenase (COX) dependence.
- To determine the overall response rate and time to progression in patients with
COX-dependent recurrent NSCLC treated with celecoxib and docetaxel or pemetrexed
- To determine the effect of celecoxib on the urinary metabolites of PGE_2 , PGI_2, and
thromboxane in patients with COX-dependent recurrent NSCLC.
- To correlate changes in urinary PGE-M and survival with intratumoral expression of
COX-2, mPGES, and 15-PGDH as assessed by IHC.
OUTLINE: Patients with no prior taxane exposure receive docetaxel IV over 1 hour on day 1;
patients with prior taxane exposure or for whom docetaxel treatment is contraindicated
receive pemetrexed disodium IV over 10 minutes on day 1. Treatment with docetaxel or
pemetrexed disodium repeats every 3 weeks for up to 6 courses in the absence of disease
progression or unacceptable toxicity. All patients receive oral celecoxib twice daily
beginning 5-7 days prior to the first docetaxel or pemetrexed disodium infusion and
continuing for up to 1 year in the absence of disease progression or unacceptable toxicity.
Patients undergo blood and urine sample collection at baseline and periodically during study
for biomarker correlative studies. Urine samples are assessed for PGE-M levels. Blood
samples are analyzed for serum celecoxib levels, VEGF, endostatin, and cytokine assays.
After completing the last dose of celecoxib, patients are followed at 4-6 weeks and then
every 3 months thereafter for up to 2 years from study entry.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
two years from date of registration
Leora Horn, MD
Vanderbilt-Ingram Cancer Center
United States: Food and Drug Administration
VICC THO 0730
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|Vanderbilt-Ingram Cancer Center - Cool Springs||Nashville, Tennessee 37064|
|Vanderbilt-Ingram Cancer Center at Franklin||Nashville, Tennessee 37064|