Celecoxib and Docetaxel or Pemetrexed in Treating Patients With Advanced Recurrent Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: celecoxib; Docetaxel; pemetrexed disodium; laboratory biomarker analysis
Intervention description: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.; 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle; 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.; Blood collection
Intervention MeSH terms: Celecoxib; Docetaxel; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent non-small cell lung cancer; stage IV non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IIIA non-small cell lung cancer

Summary:

      RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes need
      for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to
      stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving celecoxib together with docetaxel or pemetrexed may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well celecoxib given together with docetaxel or
      pemetrexed works in treating patients with advanced or recurrent non-small cell lung cancer.
    

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.