Clinical Trial Title

A Randomized Phase III Double Blind Trial Evaluating Selective COX-2 Inhibition in COX-2 Expressing Advanced Non-Small Cell Lung Cancer

Trial Summary and Conditions

RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium and celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving gemcitabine hydrochloride or pemetrexed disodium together with carboplatin is more effective with or without celecoxib in treating non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying gemcitabine hydrochloride, pemetrexed disodium, and carboplatin to compare how well they work when given together with celecoxib or a placebo in treating patients with advanced non-small cell lung cancer.

Data Summary

See Data Dictionary.

Study Objectives

PRIMARY OBJECTIVES: 1. To confirm the beneficial effect of gemcitabine hydrochloride or pemetrexed disodium in combination with carboplatin with or without celecoxib in patients with advanced non-small cell lung cancer that expresses COX-2. SECONDARY OBJECTIVES: 1. To describe the response rate in patients treated with these regimens; 2. To describe the distribution of progression-free survival (PFS) and overall survival of patients treated with these regimens; 3. To compare the PFS of patients with COX-2 index >= 2 (adjusting for CYP2C9 genotype and celecoxib trough concentrations as covariates) treated with these regimens; 4. To correlate urinary PGE-M level with COX-2 expression, COX-2 inhibition, and outcome; 5. To evaluate the association between the -765G/C polymorphism in PTGS2 and COX-2 expression in non-small cell lung cancer specimens; 6. To characterize a trough plasma celecoxib concentration which will be used as a measure of patient adherence to study treatment and which may be used in future studies for correlations with genotype and pharmacodynamic outcomes.

Outcome Measures

PRIMARY OUTCOME MEASURES: 1. Progression-free Survival. SECONDARY OUTCOME MEASURES: 1. Overall Survival; 2. Response Rate; 3. Incidence of Toxicities as Assessed by NCI CTCAE v. 4.0; 4. Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the First Quartile (Q1); 5. Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the Median Quartile (Q2); 6. Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the Third Quartile (Q3).

ClinicalTrial.gov

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

• NCT01041781

NCI Description

Dataset NCT01041781-D1-Dataset.csv (c30801) is one of 2 datasets associated with PubMed ID 28489511. This dataset contains information that will allow you to reproduce the baseline characteristics table and primary analysis. In Table A5, there is a typo in the median number of OS months for Celecoxib patients with COX-2 >= 2. The correct numbers should be 15.73 (11.50-18.96) and they are the same as those present on this shared dataset.