Erlotinib Hydrochloride With or Without Celecoxib in Treating Patients With Stage IIIB-IV Non-Small Cell Lung Cancer
Condition: Recurrent Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: erlotinib hydrochloride; celecoxib; placebo; laboratory biomarker analysis; immunohistochemistry staining method; fluorescence in situ hybridization; mutation analysis; protein expression analysis; gene expression analysis
Intervention description: Given orally; Given orally; Given orally; Correlative studies; Correlative studies; Correlative studies; Correlative studies; Correlative studies; Correlative studies
Intervention MeSH terms: Celecoxib; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      RATIONALE: Erlotinib hydrochloride and celecoxib may stop the growth of tumor cells by
      blocking some of the enzymes needed for cell growth. Celecoxib may also stop the growth of
      lung cancer by blocking blood flow to the tumor. Giving erlotinib hydrochloride together with
      celecoxib may kill more tumor cells.

      PURPOSE: This randomized phase II trial is studying how well giving erlotinib hydrochloride
      together with celecoxib works compared with erlotinib hydrochloride alone in treating
      patients with stage IIIB-IV non-small cell lung cancer.
    

Eligibility criteria:

        Inclusion

          -  Pathologically proven NSCLC, stage IIIB (defined as: with pleural effusion or
             recurrence after mediastinal radiation and chemotherapy) or IV

          -  Available tumor tissue for mutation screening

          -  Measurable stage IIIb or IV disease by RECIST guidelines

          -  ECOG performance status of 0 or 1

          -  Progressive disease despite >= 1 prior chemotherapy regimens as standard of care or
             subject's refusal or inability to receive standard chemotherapy

          -  Normal renal function (defined as serum creatinine =< 2mg/dl)

          -  Normal liver function (defined as serum total bilirubin =< 1.5, and serum
             transaminases =< 2.5X the upper limits of normal [ULN]); if liver metastases are
             present, serum transaminases > 5X the ULN

          -  No evidence of coagulopathy (defined as PT and/or PTT =< 1.5X ULN or platelets >=
             100,000)

          -  No evidence of leukopenia (defined as absolute neutrophil count >= 1,500 mm^3)

          -  Negative pregnancy test prior to initiation of treatment and adequate contraception
             throughout treatment

        Exclusion

          -  Cytotoxic chemotherapy agents within 4 weeks of initiating treatment; all toxicities
             must be recovered to baseline or NCI CTCAE v3.0 Grade 1 from all acute effects of
             prior cancer treatment, except alopecia or any clinically insignificant effect, prior
             to study initiation

          -  Evidence of NYHA class III or greater cardiac disease, history of myocardial
             infarction, cerebral vascular accident, symptomatic ventricular arrhythmia, or
             symptomatic conduction abnormality

          -  Non-cytoxic therapy within 2 weeks of initiating treatment ; all toxicities must be
             recovered to baseline or NCI CTCAE v3.0 Grade 1 from all acute effects of prior cancer
             treatment, except alopecia or any clinically insignificant effect, prior to study
             initiation

          -  Prior radiotherapy to target lesions is not permitted unless completed more than 4
             weeks prior to treatment within the study and that there has been documented
             progression at these sites (Radiotherapy to non-target lesions is permitted within 2
             weeks of study entry provided all acute effects of the radiotherapy have resolved at
             least grade 1)

          -  Comorbid disease or a medical condition that would impair the ability of the subject
             to receive or comply with the study protocol

          -  Prior malignancy within the last 3 years with the exception of non-melanoma skin
             cancer or cervical cancer in situ

          -  Hypersensitivity of erlotinib or celecoxib or to any of the excipients of these
             products

          -  Hypersensitivity to sulfonamides, aspirin or other NSAIDS

          -  Prior history of EGFR inhibitor for the treatment of cancer

          -  Previous history of gastrointestinal ulceration, bleeding or perforation

          -  Concurrent use of COX-2 inhibitors or other NSAIDS (For subjects on NSAIDS prior to
             study initiation, cessation of the drug for 72 hours prior to study entry is required)

          -  Chronic or concurrent use of steroids (topical steroids are acceptable if medically
             indicated)

          -  Subjects who require treatment with fluconazole or lithium

          -  Any evidence of clinically active interstitial lung disease (patients with chronic
             stable radiographic changes who are asymptomatic need not be excluded)

          -  Renal insufficiency (defined as serum creatinine > 2 mg/dl)

          -  Liver insufficiency (defined as serum total bilirubin > 1.5, or serum transaminases >
             2.5C the upper limits of normal [ULN]); if liver metastases are present, serum
             transaminases > 5X the ULN

          -  Coagulopathy (defined as PT and/or PTT > 1.5X ULN or platelets < 100,000)

          -  Leukopenia (defined as absolute neutrophil count < 1,500/mm^3)

          -  Pregnancy or inadequate contraception

          -  Lactating females

          -  Active CNS metastasis (stable, treated CNS metastasis acceptable)