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