Clinical trial NCT00520845 (phase 2, status: terminated)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: celecoxib, docetaxel, pemetrexed disodium
SMILES: COC1=CC=C(C=C1)C(=O)CC(=O)C1=CC=C(C=C1)C(C)(C)C, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@@](CCC(O)=O)(NC(=O)C1=CC=C(CCC2=CNC3=C2C(O)=NC(=N)N3)C=C1)C(O)=O
Reason stopped: 
    slow accrual
  
Eligibility criteria:

        Eligibility Criteria:

          -  Cytologically or histologically confirmed "COX dependent" non-small cell lung cancer.

          -  COX dependency is defined by change in urinary PGE-M levels following a "run-in" phase
             of celecoxib.

          -  Previous treatment with ≤2 different chemotherapy regimens one of which must have been
             platinum-based (cisplatin or carboplatin) chemotherapy.

          -  Age ≥18 years

          -  ECOG PS 0, 1 or 2.

          -  Measurable or evaluable disease.

          -  At least 3 weeks post major surgery, chemotherapy or radiotherapy & recovered from all
             toxicities.

          -  Expected survival of at least 2 months.

          -  CNS metastases permitted provided the patient has adequately recovered from
             radiotherapy includes stereotactic therapy) or surgery.

          -  Adequate renal function: serum creatinine ≤1.8 mg/dl &/or CrCl >50 cc/min

        Eligibility According to Liver Function:

        AST:

        </= 1.5 ULN-Docetaxel; </= 2.5 ULN-Pemetrexed (Liver parameters to be used for pemetrexed
        in the absence of proven or radiographically suspected liver metastases.); </= 5.0
        ULN-Pemetrexed (Liver parameters to be used for pemetrexed only in the presence of proven
        or radiographically suspected liver metastases.)

        Alk Phosphatase:

        </= 2.5 ULN-Docetaxel; </= 2.5 ULN-Pemetrexed (Liver parameters to be used for pemetrexed
        in the absence of proven or radiographically suspected liver metastases.); </= 5.0
        ULN-Pemetrexed (Liver parameters to be used for pemetrexed only in the presence of proven
        or radiographically suspected liver metastases.)

        Total Bilirubin:

        </= 1.5 ULN-Docetaxel; </= 1.5 ULN-Pemetrexed (Liver parameters to be used for pemetrexed
        in the absence of proven or radiographically suspected liver metastases.); </= 2.5
        ULN-Pemetrexed (Liver parameters to be used for pemetrexed only in the presence of proven
        or radiographically suspected liver metastases.)

          -  Adequate hematologic function: ANC≥1500/mm3 & platelets ≥100,000/mm3

          -  Female patients cannot be pregnant and must use contraception if of childbearing age

          -  Lactating women are excluded.

          -  Peripheral neuropathy must be CTC grade ≤2

          -  Patients must not currently be on non-steroidal anti-inflammatory agents or other
             COX-2 inhibitors (Must be off for at least ≤7 days)

          -  Written informed consent.

        Exclusion Criteria:

          -  More than two prior chemotherapy regimens for recurrent or relapsed NSCLC.

          -  COX Independent as defined by change in urinary PGE-M levels following a "run-in"
             phase of celecoxib.

          -  Previous treatment with both docetaxel and pemetrexed

          -  History of greater than grade 2 allergic reaction to celecoxib or any other
             non-steroid anti-inflammatory agent including aspirin, ibuprofen, or indomethacin.

          -  History of allergy to compounds containing boron or mannitol.

          -  History of allergy to sulfonamides.

          -  Concomitant use of Warfarin, but low dose Coumadin allowed for port prophylaxis

          -  Recent (past 4 weeks) coronary artery bypass graft (CABG) surgery.

          -  Inadequate organ function:

          -  Serum creatinine ≥1.8 mg/dl or a calculated CrCl <45 cc/min.

          -  AST >1.5 upper limits of normal (ULN); alkaline phosphatase >2.5 ULN; & bilirubin >1.5
             ULN

          -  ANC<1500/mm3 & platelets <100,000/mm3

          -  Active pregnancy or inability or unwillingness to employ appropriate contraception.

          -  Small cell carcinoma histology.

          -  Prior malignancy within 5 years of diagnosis of NSCLC. Exceptions include basal cell
             or non-metastatic squamous cell carcinomas of the skin, cervical carcinoma in situ or
             FIGO stage I cervical carcinoma, or other cancer history considered not clinically
             significant by the principal investigator.