Clinical trial NCT00923949 (phase 2, status: terminated)
Conditions: non-small-cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: pioglitazone
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O
Reason stopped: 
    study never published; terminated early due to low accrual.
  
Eligibility criteria:

        -  INCLUSION CRITERIA:

               1. Adult patients with newly diagnosed stage Ia-IIb resectable non-small cell lung
                  cancer who will be undergoing definitive surgery. If histologic confirmation of
                  lung cancer has not previously been made, the baseline study bronchoscopy, as
                  outlined in section 3.6.2, or computed tomography (CT)-guided biopsy with tissue
                  saved for protocol use may be used to document NSCLC, after obtaining informed
                  consent. Should the bronchoscopy or CT-guided biopsy be negative for non-small
                  cell lung cancer (NSCLC), the patient will be taken off study prior to drug
                  treatment. At National Cancer Institute (NCI), histologic confirmation of the
                  diagnosis will be performed by the NCI Laboratory of Pathology.

               2. Age greater than or equal to 18 years of age.

               3. Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal
                  to 2.

               4. Patients must have the capacity and willingness to sign a written informed
                  consent and demonstrate willingness to comply with an oral regimen.

               5. The time between initial diagnosis and the scheduled surgery date allow for the
                  subject to receive a minimum of 2 weeks or a maximum of 6 weeks treatment with
                  pioglitazone. The maximum time between enrollment on this trial and surgery will
                  be 6-weeks and there will be no delay between the end of pioglitazone treatment
                  and surgery.

               6. Patients must have normal organ and marrow function as defined below:

          -  absolute neutrophil count greater than or equal to 1,500/mL

          -  hemoglobin greater than 10 g/dL

          -  platelets greater than or equal to 100,000/mL

          -  Bilirubin less than 1.8 mg/dL

          -  aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than 1.5 times
             upper limits of institutional normal

          -  creatinine less than 1.5 times upper limit of institutional normal

             7. Patients must agree to swallow oral tablets.

             8. Patients who will agree to undergo two bronchoscopies as detailed in section 3.6.2
             (before treatment and at the time of surgery).

          -  For those patients who are undergoing mediastinoscopy as part of their
             standard-of-care, the pre-treatment bronchoscopy may be performed during the
             mediastinoscopy. If the patient remains eligible for definitive surgical resection
             after the mediastinoscopy, the patient may begin pioglitazone treatment on this
             protocol.

             9. Females are eligible to participate in the study if

          -  She is of non-childbearing potential as defined by having had a hysterectomy, a
             bilateral oophorectomy, a bilateral tubal ligation, or having been post-menopausal for
             greater than or equal to 1 year.

          -  She is of childbearing potential and has a negative pregnancy test within 2 weeks of
             the starting the study drug and agrees to the use of non-hormonal methods of birth
             control, e.g., barrier methods, for the duration of the study due to possible drug
             interactions.

        EXCLUSION CRITERIA:

          1. Pregnant or lactating women.

          2. Patients who are undergoing chemotherapy, treatment with biologic agents, or radiation
             therapy. Prior chemotherapy, biologic agent treatment, or radiation therapy, greater
             than 1 year ago, is allowed.

          3. Patients with greater than or equal to class II New York Heart Association (NYHA)
             congestive heart failure or history of congestive heart failure.

          4. Patients with greater than or equal to grade 2 (moderate) edema.

          5. Patients with diabetes mellitus being treated with insulin or any pharmacologic
             therapy.

          6. Patients taking gemfibrozil or rifampin, due to drug interactions with pioglitazone.

          7. Patients with uncontrolled intercurrent illness including, but not limited to, ongoing
             or active infection, active liver disease, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements.