Clinical trial NCT00222144 (phase 2, status: completed)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: gleevec and taxotere
SMILES: CN1CCN(CC2=CC=C(C=C2)C(=O)NC2=CC(NC3=NC=CC(=N3)C3=CN=CC=C3)=C(C)C=C2)CC1
Eligibility criteria:

        Inclusion Criteria:

          -  One prior chemotherapy treatment: use of single chemotherapy or a regimen containing
             more than one drug. Regimen must have a platinum agent (cisplatin or carboplatin).
             Prior biological treatment won't be counted as chemotherapy treatment. Chemoradiation
             or prior induction or adjuvant chemotherapy +/- chemoradiation will constitute one
             prior chemotherapy regimen. Patients may not have received Docetaxel. Taxol as part of
             initial therapy is allowed.

          -  Documented recurrent/progressive disease by radiographic exam (CT scan, MRI, bone scan
             or CXR), clinical exam (presence of palpable nodes) or biopsy.

          -  No signs of clinically active brain metastasis or spinal cord compression. If patient
             has brain metastasis or cord compression, patient will be eligible if stable without
             deterioration of performance status after radiation therapy and off corticosteroids.

          -  Cases with pleural effusion must have another site of disease for measurement and
             follow-up.

          -  ECOG performance status 0-1

          -  Bi-dimensional measurable disease (≥ 1 cm by CT or other radiogram; physical exam
             alone is permissible if there is no radiographically measurable tumor)

          -  Laboratory: ANC ≥ 1,500/mm3, Hemoglobin > 8g/dl, platelet ≥ 100,000/mm3, Total
             Bilirubin ≤ 1.5 mg/dl, Creatinine ≤ 2.0 mg/dl, Transaminase (AST/ALT) ≤ 2.5 X upper
             normal limit if ALK phosphatase is ≤ Upper normal limit OR ALK may be up to 4X ULN if
             transaminase are ≤ ULN.

          -  Age ≥ 18 years old

          -  Histologic or cytologic diagnosis of NSCLC, biopsy at diagnosis or on recurrence.
             Histology may include large cell, squamous cell, undifferentiated, bronchioalveolar or
             adenocarcinoma but not small cell lung cancer or mixed small and non-small cell lung
             cancer, or carcinoid. Mixed histology non-small cell lung cancer will be allowed,
             i.e.: large cell neuroendocrine carcinoma.

          -  IHC of the biopsy specimen, if available, for PDGF-R. Insufficient tissue will not
             preclude study enrollment.

          -  FEV1>800 cc

        Exclusion Criteria:

          -  ECOG performance status 2 or worse

          -  Psychological, familial, sociological or geographical conditions, which prevent weekly
             medical follow-up or compliance with the study protocol

          -  Radiation to more than 30% of bone marrow

          -  More than 1 different prior cytotoxic chemotherapy regimen

          -  Co-Morbid condition that would affect survival: grade III/IV cardiac problems as
             defined by New York Heart Association (e.g. end-stage congestive heart failure,
             myocardial infarction within 6 months of study), random uncontrolled blood sugar ≥300
             mg/dl, unstable angina, active infection on antibiotics, FEV1 less than 800 cc,
             patient with known chronic liver disease (i.e., chronic active hepatitis and
             cirrhosis)

          -  Use of investigational agents or chemotherapy within 4 weeks

          -  Pregnant or nursing women and women or men with reproductive potential unless using
             effective contraception throughout study and for 3 months after discontinuation of
             study drug.

          -  No other active invasive cancer. Patient is < 5 years free of another malignancy
             except for: other primary malignancy isn't currently clinically significant or
             requiring active intervention, or if other primary malignancy is a basal cell skin
             cancer or a cervical carcinoma in situ. Existence of any other malignant disease is
             not allowed.

          -  Patients with a history of hypersensitivity to taxane, Polysorbate 80 or gemcitabine
             and who could not tolerate treatment even with 24 H premedication with Decadron and
             Benadryl. (If the patient had prior hypersensitivity, but did not receive 24 H
             premedication for taxane, the patient may be eligible if he/she tolerates one cycle
             with 24 H premedication).

          -  Existing peripheral neuropathy CTC Version 3> grade 2

          -  Patient has known diagnosis of human immunodeficiency virus (HIV) infection

          -  Patients who can not take oral medication. Percutaneous gastrostomy feeding tube will
             be allowed if Gleevec can be given through PEG

          -  Patient who had major surgery within 2 weeks prior to study entry