Clinical trial NCT00323362 (phase 2, status: terminated)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: gemcitabine hydrochloride, imatinib mesylate
SMILES: NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F, CN1CCN(CC2=CC=C(C=C2)C(=O)NC2=CC(NC3=NC=CC(=N3)C3=CN=CC=C3)=C(C)C=C2)CC1
Reason stopped: 
    toxicity
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed non-small cell cancer

               -  Recurrent disease after adjuvant treatment OR progressive disease after 1 prior
                  treatment for recurrent or metastatic disease

          -  Received at least 1 prior chemotherapy regimen and meets the following criteria:

               -  No more than 1 prior chemotherapeutic regimen in the recurrent or metastatic
                  setting

               -  Patients who received prior chemotherapy in the adjuvant setting are eligible
                  when 1 of the following criteria is met:

                    -  In first recurrence (after 1 prior regimen)

                    -  Received first-line chemotherapy in the recurrent setting after 2 prior
                       regimens

          -  Measurable disease

               -  Must have ≥ 1 measurable target lesion outside prior radiotherapy field OR
                  radiologic confirmation of disease progression within a prior radiotherapy field

          -  No known or untreated brain metastases or carcinomatous meningitis

               -  Clinically stable, treated brain metastases allowed provided it has been > 7 days
                  since prior steroids

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  Life expectancy ≥ 3 months

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  AST and ALT ≤ 2.5 times ULN

          -  Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 3 months after
             completion of study treatment

          -  Able to swallow oral medication

          -  No concurrent medical condition that would preclude study compliance

          -  No history of allergic reaction to compounds of similar chemical or biological
             composition to gemcitabine hydrochloride or imatinib mesylate

          -  No uncontrolled illness that would preclude study compliance, including any of the
             following:

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Cardiac arrhythmia requiring therapy

               -  Myocardial infarction within the past 6 months

               -  Active infection

          -  No New York Heart Association class III-IV congestive heart failure

          -  No chronic liver disease (i.e., chronic active hepatitis, cirrhosis)

          -  No HIV positivity

          -  No other primary malignancies within the past 5 years, except carcinoma in situ of the
             cervix or nonmelanoma skin cancer

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)

          -  At least 3 weeks since prior anti-vascular endothelial growth factor therapy and
             recovered

          -  At least 3 weeks since prior radiotherapy and recovered

          -  More than 28 days since prior and no other concurrent investigational or commercial
             agents

          -  More than 2 weeks since prior major surgery

          -  No prior gemcitabine hydrochloride or imatinib mesylate for metastatic disease

          -  No prior tyrosine kinase inhibitor, except for gefitinib or erlotinib hydrochloride

          -  No concurrent therapeutic warfarin (prophylactic warfarin therapy ≤ 1 mg daily
             allowed)

          -  No other concurrent medications that would preclude study compliance

          -  No concurrent chronic systemic corticosteroids