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
Intervention: cisplatin; pemetrexed disodium; adjuvant therapy; therapeutic conventional surgery; fludeoxyglucose F 18
Intervention MeSH terms: Pemetrexed; Fluorodeoxyglucose F18
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
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

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.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

          -  Stage IB, II, IIIA, or IIIB (T4, N0-1) disease

               -  Staging must have been performed 4 weeks prior to study entry with a CT scan of
                  chest, upper abdomen, and fludeoxyglucose F 18 (^18FDG) positron emission
                  tomography (PET) scan

               -  Mediastinal evaluation and staging based on combination of CT scan and FDG-PET
                  results

          -  If N1 or N2 nodes are found by FDG-PET or CT scan, metastases must be ruled out by
             brain MRI

          -  Measurable and resectable disease

               -  T4 lesions must be resectable

          -  Eligible for curative surgery

          -  No malignant pleural effusion

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  ECOG 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count ≥ 1,250/mm^3

          -  Platelet count ≥ 100,000/mm^3

        Hepatic

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  AST and ALT ≤ 3.0 times ULN

        Renal

          -  Creatinine clearance ≥ 45 mL/min

        Pulmonary

          -  Adequate pulmonary reserve to undergo surgery

               -  Predicted FEV_1 > 0.8 L after resection

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 3 months after
             completion of study treatment

          -  Able to take corticosteroids

          -  Able to take folic acid or vitamin B_12 supplements

          -  No other malignancy within the past 5 years except nonmelanoma skin cancer or
             noninvasive cervical cancer

          -  No concurrent serious or uncontrolled disorder that would preclude study participation

          -  No type I diabetes mellitus

               -  Type II diabetes mellitus allowed if glucose is 80-150 mg/dL

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No concurrent immunotherapy

          -  No concurrent prophylactic filgrastim (G-CSF)

          -  No concurrent thrombopoiesis-stimulating agents

        Chemotherapy

          -  At least 5 years since prior chemotherapy

        Endocrine therapy

          -  No concurrent anticancer hormonal therapy

        Radiotherapy

          -  No prior radiotherapy to the chest

          -  No concurrent curative or palliative radiotherapy

        Surgery

          -  Not specified

        Other

          -  At least 30 days since prior non-FDA-approved or investigational agents

          -  At least 5 days since prior aspirin or other nonsteroidal anti-inflammatory agents (8
             days for long-acting agents [e.g., piroxicam])

          -  No other concurrent anticancer therapy

          -  No other concurrent investigational agents