A Comparison of FLT to FDG PET/CT in the Early Assessment of Chemotherapy Response in Stage IB-IIIA Resectable NSCLC
Condition: Recurrent Non-Small Cell Lung Carcinoma; Stage IB Non-Small Cell Lung Carcinoma; Stage IIA Non-Small Cell Lung Carcinoma; Stage IIB Non-Small Cell Lung Carcinoma; Stage IIIA Non-Small Cell Lung Cancer; Stage IV Non-Small Cell Lung Cancer
MeSH terms: Carcinoma; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Cisplatin; CT; Docetaxel; FDG; FLT; PET/CT; Surgery
Intervention description: Given IV; Undergo FDG PET/CT, FLT PET/CT and thoracic CT; Given IV; Undergo FDG PET/CT; Undergo FLT PET/CT; Undergo FDG PET/CT and FLT PET/CT; Undergo surgery
Intervention MeSH terms: Deoxyglucose; Alovudine; Dideoxynucleosides; Cisplatin; Docetaxel; Fluorodeoxyglucose F18
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      This study is being done to compare a special type of Positron Emission Tomography (PET) scan
      with CT scan in patients with surgically removable lung cancer to see which method is more
      useful in measuring a response to treatment. A PET scan uses small amounts of radioactive
      material injected into the blood to show the internal workings of the body. In this study, we
      will use two radioactive materials: 18F-FLT (referred to as FLT) and 18F-FDG (referred to as
      FDG). FDG is used routinely in the staging of lung cancer and is approved by the FDA for that
      purpose. FLT is used in the special type of PET scan being assessed by this study. In
      addition the study will assess the effects of the combination of docetaxel and cisplatin
      (chemotherapeutic drugs) on certain pathological characteristics of the tumor. The
      combination of docetaxel and cisplatin is approved by the Food and Drug Administration (FDA)
      for the treatment of advanced/metastatic NSCLC (non-small cell lung cancer). It is not
      approved for use in patients who have surgically removable NSCLC. In such cases cisplatin is
      used as a single drug therapy before surgery. The FDA is allowing the use of docetaxel along
      with cisplatin in this research study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed clinical stage IB - IIIA
             non-small cell lung cancer; stage IV patients with oligometastatic disease with
             metastases that have been treated definitively with radiation or surgery are also
             eligible (ie: solitary brain or adrenal metastasis); mixed tumors will be categorized
             by the predominant cell type unless small cell elements are present in which case the
             patient is ineligible; note: tissue samples from biopsy confirmation will be required

          -  Patients must be surgically resectable as determined by a thoracic surgeon

          -  Patients must have measurable disease per RECIST 1.1, defined as at least one lesion
             that can be accurately measured in at least one dimension (longest diameter to be
             recorded) as >= 10 mm with spiral CT scan

          -  Life expectancy of greater than 12 weeks

          -  ECOG performance status < 1

          -  Leukocytes >= 3,000/uL

          -  Absolute neutrophil count >= 1,500/uL

          -  Platelets >= 100,000/uL

          -  Total bilirubin =< 1.5 x institutional upper limit of normal

          -  AST (SGOT) =< 1.5 x institutional upper limit of normal

          -  Alkaline phosphatase =< 2.5 x institutional upper limit of normal

          -  Creatinine =< 1.5 x institutional upper limit of normal OR creatinine clearance >= 60
             mL/1.73 m2 for patients with creatinine levels above institutional normal

          -  Fasting screening blood glucose =< 200 mg/dL

          -  Pregnant women are excluded from this study; breastfeeding should be discontinued if
             the mother is treated with either agent

        Exclusion Criteria:

          -  Women of child-bearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control; abstinence) prior to study entry and for
             the duration of study participation; should a woman become pregnant or suspect she is
             pregnant while participating in this study, she should inform her treating physician
             immediately

          -  Patients may not be receiving any other investigational agents

          -  Patients must not have received prior systemic chemotherapy or radiation therapy for
             lung cancer; prior systemic chemotherapy or radiation for other malignancies over
             three years prior to study enrollment may be allowed at the discretion of the
             principal medical investigator

          -  Prior malignancy in the past 3 years, other than non-melanoma skin cancer and in situ
             carcinoma of the cervix

          -  Patients who report a hearing deficit at baseline, even if it does not require a
             hearing aid or intervention, or interfere with activities of daily life (Common
             Terminology Criteria for Adverse Events [CTCAE] grade 2 or higher)

          -  Peripheral neuropathy > CTCAE grade 1

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to cisplatin, docetaxel, or other agents used in the study

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, uncontrolled diabetes, symptomatic congestive heart failure, unstable
             angina pectoris, cardiac arrhythmia, or psychiatric/social situations that would limit
             compliance with study requirements

          -  HIV-positive patients on combination antiretroviral therapy are ineligible

          -  Inability to comply with study and/or follow-up procedures