Imatinib Mesylate and Paclitaxel in Treating Older Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Condition: Malignant Pleural Effusion; 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; Pleural Effusion, Malignant; Pleural Effusion
Intervention: imatinib mesylate; paclitaxel
Intervention description: Given PO; Given IV
Intervention MeSH terms: Paclitaxel; Imatinib Mesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic or cytologic diagnosis of non-small cell lung cancer

          -  At least one site of measurable disease, as defined by the modified RECIST criteria

          -  Stage IIIB with pleural effusion or Stage IV disease; includes patients who received
             surgery alone for early stage disease, now in relapse with advanced disease; staging
             is according to the American Joint Committee on Cancer classification scheme, 6th
             edition

          -  Total bilirubin < 1.25 x upper limit of normal (ULN)

          -  Baseline absolute neutrophil count >= 1500/uL

          -  Baseline platelet count >= 100,000/uL

          -  ECOG Performance Status 0, 1 or 2 at the time of informed consent

          -  Written, voluntary consent

          -  Patients with reproductive potential must use an acceptable contraceptive method, such
             methods include: 1) Male hormonal contraception; 2) Partner without reproductive
             potential, including post-menopausal status or history of tubal ligation; 3) Partner
             with intrauterine device (IUD) or contraceptive vaginal ring; 4) Partner takes oral
             contraceptive pill, wears contraceptive patch, or has contraceptive implant; 5)
             Routine use of barrier method, such as condoms or diaphragm, during sexual intercourse

          -  AST and ALT =< 2.5 x ULN

          -  Creatinine =< 1.5 x ULN

        Exclusion Criteria:

          -  Uncontrolled brain metastasis; patients with known brain metastasis must have
             completed treatment with surgery, radiation or both; in addition, they must be off
             corticosteroids

          -  Symptomatic neuropathy (Grade 2 or higher)

          -  Prior chemotherapy for advanced non-small cell lung cancer (Prior adjuvant,
             neoadjuvant, or chemoradiotherapy for NSCLC is permitted, provided at least 6 months
             elapsed prior to documented metastatic recurrence)

          -  Patient is < 5 years free of another primary malignancy, except: a) if the other
             malignancy is basal cell carcinoma or cervical carcinoma in situ or b) if the other
             primary malignancy is not considered clinically significant and is requiring no active
             intervention

          -  Prior radiation therapy to > 25% of bone marrow

          -  Grade III/IV congestive heart failure, as defined by NYHA criteria, or myocardial
             infarction within 6 months

          -  Any serious or uncontrolled concomitant disorder that, in the opinion of the
             investigator, would compromise the patient's ability to complete the study

          -  Patient has known chronic liver disease, e.g., diagnosis of chronic active hepatitis
             or cirrhosis

          -  Major surgery two weeks prior to study treatment

          -  Patient with any significant history of non-compliance to medical regimens or with
             inability to grant reliable informed consent

          -  Any condition requiring continuous administration of systemic corticosteroids

          -  The patient is on therapeutic anti-coagulation with warfarin

          -  The administration of any other anticancer agents including chemotherapy and biologic
             agents is NOT permitted

          -  The use of other concurrent investigational drugs is not allowed

          -  Participants in this study must avoid grapefruit juice or other grapefruit-containing
             products for the duration of treatment with imatinib