0822GCC: Phase 2 Study of Efficacy and Safety of Apricoxib/Placebo With Docetaxel or Pemetrexed in Non-Small Cell Lung Cancer

Inclusion Criteria

• Pathologically determined stage IV non-small cell lung cancer (NSCLC), including stage IIIb (pleural effusion) (histology or cytology acceptable).
• Documented progression after 1 prior platinum-based chemotherapy. No more than one prior chemotherapy regimen is permitted. Patients may have also received erlotinib (before, after or concurrently with platinum based therapy).
• Measurable disease by RECIST criteria
• Age at least 18 years.
• ECOG performance status of 0-2.
• Required Laboratory Values (within 28 days before randomization) :
• Hb ≥ 9.0gm/dL; transfusions permitted
• ANC ≥ 1500/mm3
• Platelets ≥ 100,000/mm3
• INR ≤ 1.5
• Serum creatinine (Cr) within normal limits for laboratory OR Creatinine clearance greater than or equal to 45 ml/min. 24 hour measured CCr is also acceptable (calculated by the Cockcroft and Gault equation).
• SGOT and SGPT 3 weeks prior to initiating study treatment. Screening for urinary PGE-M suppression may begin during this time period.
• Evidence of New York Heart Association class III or greater cardiac disease. History of myocardial infarction, stroke, ventricular arrhythmia, or symptomatic conduction abnormality within 12 months.
• Concurrent severe or uncontrolled medical disease that could compromise the safety of the patient or compromise the ability of the patient to complete the study.
• Known HIV infection or AIDS. Testing not required.
• Symptomatic central nervous system metastases; the patient must be stable after radiotherapy for ≥ 2 weeks. Patients must be off all steroid or antiseizure medications for this indication for ≥ 2 weeks. Patients with CNS metastases that are untreated are eligible if there is no evidence of midline shift, requirement for steroids or antiseizure medications or neurologic symptoms.
• History of upper GI bleeding, ulceration, or perforation within the past 5 years.
• Concurrent use of COX-2 inhibitors or other NSAIDs for 2 days prior to the first dose of study treatment and during study, including aspirin for 7 days prior to the first dose of study treatment and during study.
• Previous COX-2 inhibitor therapy for this diagnosis.