0822GCC: Phase 2 Study of Efficacy and Safety of Apricoxib/Placebo With Docetaxel or Pemetrexed in Non-Small Cell Lung Cancer
Condition: Lung Cancer; Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: apricoxib; Placebo; Docetaxel or Pemetrexed
Intervention description: Oral apricoxib tablets will be provided as white or off-white film-coated tablets available in 100mg strength to be taken every day; Oral placebo tablets will be provided as white or off-white film-coated tablets to be taken every day; Docetaxel 75mg/m2 or Pemetrexed 500mg/m2 given as an IV infusion every 21 days. TheTreating physician will determine chemotherapy drug as per his usual practice.
Intervention MeSH terms: Docetaxel; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 109.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: apricoxib; docetaxel; pemetrexed; Stage IIIb or Stage IV

Summary:

      The primary objective is to determine the anti-tumor activity of the combination of apricoxib
      + either docetaxel (AP/DC) or pemetrexed (AP/PE) compared with placebo + either docetaxel
      (P/DC) or pemetrexed (P/PE) as measured by progression free survival in patients with Stage
      IIIb (pleural effusion)or Stage IV non-small cell lung cancer (NSCLC).
    

Eligibility criteria:

        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.

        Exclusion Criteria:

          -  Pregnant or breast feeding

          -  Known hypersensitivity to apricoxib, docetaxel, other drugs formulated with
             polysorbate 80, pemetrexed, sulfonamides, aspirin, or other NSAIDs.

          -  Radiation therapy within 2 weeks or chemotherapy within 3 weeks or non-cytotoxic
             investigational agents within 3 weeks of initiating study treatment or patients who
             have not recovered from adverse effects due to agents administered > 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.