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 \< 2 X the ULN; if liver metastases are present then must be \< 5 X the ULN
• •* Bilirubin ≤ Institutional ULN
• •* Albumin ≥ or equal to 2.5 mg/dl
• •May have been treated with anti-EGFR kinase therapy in addition to a platinum based therapy or concurrently with platinum therapy.
• •Provide written informed consent and HIPAA authorization and agree to abide by the study restrictions and return for the required assessments.
• •Women of child-bearing potential must have negative pregnancy test (serum B-HCG) with a sensitivity of at least 50 mIU/L within 7 days prior to the initiation of treatment and must have used effective contraception (recommended to be two reliable forms of contraception used simultaneously) or must have been sexually abstinent for at least 4 weeks prior to the negative pregnancy test through entry in the study.
• •Female patients and male patients with female partners of child-bearing potential must agree to sexual abstinence or to practice effective contraception (recommended to be two reliable forms of contraception used simultaneously). At least one non-hormonal method strongly recommended. Male patients with female sexual partners who are pregnant, or of childbearing potential must agree to use condoms during and for at least 1 month after the last dose of apricoxib.
• •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.