Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: carboplatin; paclitaxel albumin-stabilized nanoparticle formulation; protein expression analysis; immunoenzyme technique; immunohistochemistry staining method; laboratory biomarker analysis
Intervention MeSH terms: Paclitaxel; Carboplatin; Albumin-Bound Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent non-small cell lung cancer; squamous cell lung cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle
      formulation and carboplatin, work in different ways to stop the growth of tumor cells, either
      by killing the cells or by stopping them from dividing. Giving more than one drug
      (combination chemotherapy) may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle
      formulation given together with carboplatin works in treating patients with stage IIIB, stage
      IV, or recurrent non-small cell lung cancer.
    

Eligibility criteria:

        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