Azacitidine in Treating Patients With Previously Treated Advanced Non-Small Cell Lung Cancer
Condition: Recurrent Lung Non-Small Cell Carcinoma; Stage IV Lung Non-Small Cell Cancer AJCC v7
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Azacitidine; Diagnostic Laboratory Biomarker Analysis; Pharmacological Study
Intervention description: Given subcutaneously; Correlative studies; Correlative studies
Intervention MeSH terms: Azacitidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II clinical trial is studying how well azacitidine works in treating patients with
      previously treated advanced non-small cell lung cancer. Drugs used in chemotherapy, such as
      azacitidine, work in different ways to stop the growth of tumor cells, either by killing the
      cells or by stopping them from dividing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced (stage 4 or recurrent) NSCLC, not eligible for any curative intent treatment

               -  Tumor must be histologically or cytologically confirmed

          -  Measurable disease (as defined by RECIST criteria)

          -  Patients may have up to two (and at least one) prior cytotoxic regimens in the
             metastatic setting

               -  Prior adjuvant chemotherapy following resection or definitive chemo-radiation for
                  patients with locally advanced disease is not included in this

               -  Allowable systemic therapy in the metastatic setting includes 2 cytotoxic
                  regimens and erlotinib and/or other non-cytotoxic drugs (i.e., erlotinib,
                  sorafenib, and other tyrosine kinase inhibitors do not count as a "cytotoxic
                  regimen")

               -  Prior adjuvant therapy or definitive chemo-radiation is allowed if completed >
                  six months before the onset of "first-line" therapy in the metastatic setting -
                  in this setting, adjuvant or definitive chemo-radiation will not "count" as one
                  of the two cytotoxic regimens; if however, the patient relapses within six months
                  from completion of adjuvant or definitive chemoradiation, then this therapy will
                  be considered the first-line cytotoxic therapy

               -  In the unusual circumstance where patients receive "adjuvant" therapy following
                  resection of oligo-metastatic disease (for example brain metastasis and lung
                  primary resections) and the treating physician decides to administer chemotherapy
                  following all surgery, this will be considered "adjuvant" therapy and the same
                  rules as noted above will apply for initiation of first-line systemic therapy

          -  No patients with uncontrolled brain metastases or leptomeningeal disease

               -  Patients with controlled brain metastases are allowed

          -  ECOG performance status 0-2

          -  Absolute neutrophil count ≥ 1.5 x 10^9/L

          -  Platelets ≥ 100,000 x 10^9/L

          -  Hemoglobin ≥ 9.0 gm/100 mL

          -  Total bilirubin ≤ 1.5 mg/dL

          -  AST and ALT ≤ 2.5 x ULN

          -  Creatinine ≤ 1.5 mg/dL OR calculated creatinine clearance > 50 mL/min

          -  No patients who are pregnant

          -  Women of childbearing potential must have a negative pregnancy test

          -  The patient must be willing to use adequate contraception for the duration of study
             treatment and up to four weeks following the last dose of drug

          -  Archival diagnostic material sufficient for microRNA evaluation/assessment is
             preferred, though optional

               -  The presence of archival material will not preclude the need for pre and post
                  treatment biopsies

          -  Willing to undergo biopsy pre-treatment and following first cycle

               -  Biopsy may be from any accessible site (primary or metastatic)

          -  No known HIV or hepatitis B or C (though testing for this is not required)

          -  No uncontrolled intercurrent illness including, but not limited to:

               -  Symptomatic CHF

               -  Unstable angina pectoris

               -  Serious cardiac arrhythmia

               -  Serious infection

               -  Psychiatric illness or social situations that would limit compliance with study
                  requirements

          -  No patients who have significant psychiatric illness that, in the opinion of the
             principal investigator, would prevent adequate informed consent or render therapy
             unsafe

          -  Patients may not have had a prior invasive malignancy except for adequately treated
             non-melanoma cell skin cancer, in situ cervical cancer, or other cancer for which the
             patient has been disease-free for 2 years

               -  For example, a stage 1 (T1c) prostate cancer 2 years prior to a diagnosis of
                  NSCLC would not be exclusionary, however, a metastatic prostate cancer currently
                  receiving hormonal or chemotherapy would be excluded

          -  No other concurrent palliative radiotherapy

          -  Recovered from prior surgery, radiation, or chemotherapy to ≤ grade 2 toxicity

          -  Palliative radiation or surgical procedures (for example, endobronchial therapy) is
             allowed, but must have been completed > 2 weeks prior to starting treatment

          -  No other investigational or commercial agents or therapies may be administered with
             the intent to treat the patient's malignancy

          -  No other concurrent investigational therapy