A Modified Two Stage Phase II Study of Combination Abraxane and Radiation for Stage III Non-Small Cell Lung Cancer
- Histologically confirmed NSCLC.
- Clinical or pathologic stage IIIA (T1-3N2M0, T3N1M0) and IIIB (Any T N3M0, T4 Any N
M0) diseases according to the American Joint Committee of Cancer criteria.
- Patients with malignant pleural effusion will be excluded.
- The primary tumor must be radiographically measurable.
- Age > 18.
- Karnofsky performance status > 70 or Zubrod PS 0 or 1.
- FEV1 sufficient for patients to tolerate radiation therapy, which is at the
discretion of the radiation oncologist, usually > 800 ml, but may be higher or lower
depending on the volume of radiotherapy portal, which is a variable of the tumor
- WBC > 3000; platelet count > 100,000; absolute neutrophil counts > 1,500; HGB > 9.0
g/dl, serum creatinine < 1.5 mg/dl or creatinine clearance > 60 ml/min. Laboratory
values must be obtained < 4 weeks prior to registration.
- Patients with equivocal enlargement of adrenal gland(s) on CT scan, or a few
equivocal regional or distant lesions on any imaging studies need further imaging
study (PET, bone scan, or others) or biopsy to rule out distant metastasis.
- Patients must have adequate liver functions: AST and ALT < 2.5 x upper limit of
normal, alkaline phosphatase < 2.5 x upper limit of normal, unless bone metastasis is
present in the absence of liver metastasis. Bilirubin <1.5 mg/dL.
- Pre-existing neuropathy must not be worse than grade I.
- A signed informed consent.
- Normal organ function including EKG findings deemed acceptable for chemotherapy by
the medical oncologist.
- Patients with distant metastasis (stage IV disease).
- Patients without measurable disease.
- Patients with medical contraindication to chemotherapy or radiotherapy.
- Patients with myocardial infarction within the preceding 6 months or symptomatic
heart disease, including angina, congestive heart failure, uncontrolled arrhythmia.
- Patients with bilirubin elevated above institutional upper limit of normal (ULN) must
- Women who are pregnant or breastfeeding are not eligible.
- Other serious illnesses or medical conditions