Gemcitabine and Imatinib Mesylate in Treating Patients With Recurrent or Metastatic Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: gemcitabine hydrochloride; imatinib mesylate
Intervention description: 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.; 400 mg/day orally, given Days 1-5 and 8-12 every 21 days
Intervention MeSH terms: Gemcitabine; Imatinib Mesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent non-small cell lung cancer; stage IV non-small cell lung cancer

Summary:

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

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