FDG-Labeled PET Scan in Planning Chemotherapy in Treating Patients With Stage IIIB or IV Non-Small Cell Lung Cancer
Condition: Malignant Pleural Effusion; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Pleural Effusion, Malignant; Pleural Effusion
Intervention: carboplatin; docetaxel; gemcitabine hydrochloride; paclitaxel; computed tomography; positron emission tomography; fludeoxyglucose F 18; imaging biomarker analysis
Intervention description: Given IV; Given IV; Given IV; Given IV; Undergo FDG PET/CT; Undergo FDG PET/CT; Given IV; Correlative studies
Intervention MeSH terms: Paclitaxel; Docetaxel; Carboplatin; Gemcitabine; Fluorodeoxyglucose F18
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well fludeoxyglucose F 18 (FDG)-labeled positron emission
      tomography (PET) scan works in planning chemotherapy in treating patients with stage IIIB or
      IV non-small cell lung cancer (NSCLC). Drugs used in chemotherapy, such as paclitaxel,
      carboplatin, gemcitabine hydrochloride, and docetaxel, work in different ways to stop the
      growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Diagnostic imaging procedures, such as FDG-labeled PET scan, may help in guiding chemotherapy
      and allow doctors to plan better treatment
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed NSCLC; patients must have
             stage IIIB with malignant pleural effusion or with nodal disease so extensive that it
             is not amenable to radiotherapy with curative intent, or stage IV disease, as defined
             by the American Joint Committee on Cancer (AJCC) cancer staging handbook, 6th Edition
             (2002)

          -  Patients must have measurable disease, defined as at least one lesion that can be
             accurately measured in at least one dimension (>= 10 mm with spiral CT scan);
             patients' baseline FDG-PET scan must demonstrate a target lesion with SUV >= 2 x
             background and SUV > 3

          -  All patients must not have received treatment with conventional cytotoxic chemotherapy
             for NSCLC; patients may have had prior radiotherapy or may have been treated with the
             epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI) (i.e.
             erlotinib or gefitinib); one week must have elapsed after discontinuation, prior to
             the initial PET scan for patients previously treated with a TKI; patients who receive
             radiotherapy must have recovered from the side effects of therapy (except alopecia)
             and have measurable disease (target lesion) outside of the radiation field

          -  Life expectancy >= 3 months

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 2

          -  Absolute neutrophil count >= 1,500/mcL

          -  Platelets >= 100,000/mcL

          -  Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT]) =<
             2 x institutional ULN (< 5 x ULN for patients with liver metastases)

          -  Creatinine =< 1.5 x ULN OR creatinine clearance >= 40 mL/min/1.73 m^2 for patients
             with creatinine levels above institutional normal

          -  Patients must have baseline FDG-PET and CT scans performed at the University of
             Washington (UW)/Seattle Cancer Care Alliance (SCCA) within two weeks from the start of
             chemotherapy

          -  Asymptomatic patients with clinically stable brain metastases (treated or untreated)
             are allowed

          -  Women of child-bearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control; abstinence) throughout treatment and for
             30 days following the last dose of chemotherapy

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Patients who have received EGFR TKI (i.e. erlotinib or gefitinib) within one week
             prior to entering the study

          -  Patients may not be receiving any other investigational agents

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition agents used in the study

          -  Inability or unwillingness to take corticosteroids, which are required pre-medications
             for the chemotherapies in this trial

          -  Diabetes requiring insulin for management

          -  Patients must weigh less than 400 lbs

          -  Patients with post-obstructive pneumonia or lobar collapse

          -  Significant neuropathy (common toxicity criteria [CTC] grade > 2), as both the
             paclitaxel and docetaxel have potential for neurotoxicity

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Pregnant or breastfeeding women

          -  Patients with a detectable second malignancy are excluded, as this could confound
             tumor evaluation and affect patient survival

          -  Patients who are likely to need palliative radiation therapy for painful bony
             metastases, impending fractures, or hemoptysis