Clinical trial NCT00520845
Conditions: Lung Cancer
Keywords: recurrent non-small cell lung cancer stage IV non-small cell lung cancer stage IIIB non-small cell lung cancer stage IIIA non-small cell lung cancer
Sponsor: Vanderbilt-Ingram Cancer Center
Start date: 2007-10-01; Completion date: 2014-01-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes need for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving celecoxib together with docetaxel or pemetrexed may kill more tumor cells.

PURPOSE: This phase II trial is studying how well celecoxib given together with docetaxel or pemetrexed works in treating patients with advanced or recurrent non-small cell lung cancer.

Detailed description:
OBJECTIVES:

Primary

* 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.

Secondary

* To determine the overall response rate and time to progression in patients with COX-dependent recurrent NSCLC treated with celecoxib and docetaxel or pemetrexed disodium.
* 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.

Arms: arm 1: Either docetaxel or pemetrexed given with celecoxib
Interventions: intervention 1: celecoxib intervention 2: Docetaxel intervention 3: pemetrexed disodium intervention 4: laboratory biomarker analysis
Intervention descriptions: intervention 1: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression. intervention 2: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle intervention 3: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle. intervention 4: Blood collection

Protocol documents: