Positron Emission Tomography in Predicting Response in Patients Who Are Undergoing Treatment With Pemetrexed Disodium and Cisplatin With or Without Surgery for Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Diagnostic procedures, such as positron emission tomography (PET), (done before,
      during, and after chemotherapy) may help doctors predict a patient's response to treatment
      and help plan the best treatment. Drugs used in chemotherapy, such as pemetrexed disodium and
      cisplatin, work in different ways to stop the growth of tumor cells, either by killing the
      cells or by stopping them from dividing. Giving combination chemotherapy after surgery may
      kill any tumor cells that remain after surgery.

      PURPOSE: This phase II trial is studying how well PET works in predicting response in
      patients who are undergoing treatment with pemetrexed disodium and cisplatin with or without
      surgery for stage I, stage II, or stage III non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the effectiveness of fludeoxyglucose F 18 positron emission tomography in
           predicting radiological and pathological response in patients treated with pemetrexed
           disodium and cisplatin with or without surgery for stage IB-IIIB non-small cell lung
           cancer (NSCLC).

      Secondary

        -  Determine the safety of cisplatin and pemetrexed disodium in these patients.

        -  Determine the radiographic response rate, duration of response, and time to progression
           in patients treated with cisplatin and pemetrexed disodium.

      OUTLINE: This is a multicenter study.

        -  Fludeoxyglucose F 18 (18FDG) positron emission tomography (PET) imaging: All patients
           undergo positron emission tomography (PET) imaging of the head, neck, thorax, abdomen,
           and pelvis. Patients receive fludeoxyglucose F 18 (^18FDG) IV followed by 45 minutes of
           rest. PET imaging is done over 1 hour and 8 minutes. Patients undergo PET imaging at
           three points during the study: 4 weeks prior to treatment, after the first cycle of
           treatment, and after 3 courses of chemotherapy. Some patients then undergo surgical
           resection of the tumor.

        -  Chemotherapy: Patients receive cisplatin IV over 30 minutes and pemetrexed disodium IV
           over 10 minutes on day 1. Courses repeat every 21 days for up to 3 courses in the
           absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed every 3 months for 2 years and
      then every 6 months for 3 years.

      PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
    

Intervention name(s): cisplatin; pemetrexed disodium; adjuvant therapy; therapeutic conventional surgery; fludeoxyglucose F 18
Intervention type(s): Drug; Drug; Procedure; Procedure; Radiation
Intervention MeSH terms: Pemetrexed; Fluorodeoxyglucose F18
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I non-small cell lung cancer; stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer