Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer, squamous cell lung cancer Read More

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed advanced non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:

  • Stage IIIB disease with malignant pleural effusion
  • Stage IV disease
  • Recurrent disease
• Squamous cell histology allowed
• Not eligible for curative treatment or treatment with bevacizumab
• Measurable disease according to RECIST
• Tumor (paraffin blocks or slides) must be available for correlative biomarker studies

• No uncontrolled brain metastases (or leptomeningeal disease)

  • Controlled brain metastases allowed

    • Able to receive appropriate therapeutic radiotherapy
    • Able to taper off all steroids without symptoms suggestive of increased intracranial pressure (nausea, vomiting, focal neurologic symptoms) for at least 7 days

PATIENT CHARACTERISTICS:

• ECOG (Eastern Cooperative Oncology Group) performance status 0-2
• ANC (absolute neutrophil count) ≥ 1.5 x 10^9/L
• Platelets ≥ 100 x 10^9/L
• Hemoglobin ≥ 9.0 g/L
• Total bilirubin ≤ 1.5 mg/dL
• AST (aspartate aminotransferase) and ALT (alanine aminotransferase) < 2.5 times upper limit of normal
• Creatinine ≤ 1.5 mg/dL OR creatinine clearance > 50 mg/mL
• No known HIV or hepatitis B or C
• Not pregnant
• Negative pregnancy test
• Thrombotic or embolic event within the past 6 months allowed, provided adequately controlled with therapeutic anticoagulation
• Hemoptysis allowed, provided it is not life threatening or requires palliative procedures (e.g., endobronchial therapy or radiotherapy)

• No cardiac disease, including any of the following:

  • NYHA (New York Heart Association) class III-IV congestive heart failure
  • Unstable angina (angina symptoms at rest)
  • New onset angina (began within the past 3 months)
  • Myocardial infarction within the past 6 months
• No uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg or diastolic BP > 90 mm Hg despite optimal medical management
• No peripheral neuropathy ≥ grade 2
• No active clinically serious infection > CTCAE grade 2
• No serious non-healing wound, ulcer, or bone fracture
• No significant traumatic injury within the past 4 weeks
• No evidence or history of bleeding diathesis or coagulopathy

• No prior malignancy, except for adequately treated basal cell skin cancer, carcinoma in situ of the cervix, or other cancer for which the patient has been disease-free for 2 years

  • Stage I (T1c) prostate cancer adequately treated 2 years prior to diagnosis of NSCLC allowed, however metastatic prostate cancer currently receiving hormonal therapy or chemotherapy is not allowed
• No significant psychiatric illness, in the opinion of the principal investigator, that would prevent adequate informed consent or render therapy unsafe

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Concurrent therapeutic anticoagulation, > 325 mg acetylsalicylic acid, or chronic non-steroid anti-inflammatory drug use allowed
• At least 14 days since prior and no concurrent radiotherapy
• More than 4 weeks since prior major surgery or open biopsy