Clinical trial NCT00408460 (phase 2, status: completed)
Conditions: malignant pleural effusion, recurrent non-small cell lung cancer, stage iiib non-small cell lung cancer, stage iv non-small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: imatinib mesylate, paclitaxel
SMILES: CN1CCN(CC2=CC=C(C=C2)C(=O)NC2=CC(NC3=NC=CC(=N3)C3=CN=CC=C3)=C(C)C=C2)CC1, [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC
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