Pemetrexed Disodium and Cisplatin in Treating Patients Who Are Undergoing 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; conventional surgery; neoadjuvant therapy
Intervention description: Given IV; Given IV; Metastasis prevention/control; Undergoing tissue removal; Tumor Reduction
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage II non-small cell lung cancer; stage I non-small cell lung cancer

Summary:

      RATIONALE: 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 more than one drug (combination chemotherapy) and giving them
      before and after surgery may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving pemetrexed disodium and cisplatin
      before and after surgery works in treating patients with stage I, stage II, or stage III
      non-small cell lung cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Microscopically confirmed non-small cell lung cancer

               -  Stage IB (T2, N0, M0), IIA (T1, N1, M0), IIB (T2, N1, M0 or T3, N0, M0), or IIIA
                  (T1-3, N1-2, M0) disease

               -  Satellite lesions in one lobe (T4) (stage IIIB) allowed

          -  Meets 1 of the following criteria:

               -  Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 10 mm in
                  the longest diameter

               -  Evaluable disease, defined as lesions on chest CT scan that are not measurable
                  (e.g., ill-defined masses or mediastinal or hilar adenopathy)

          -  No metastatic disease except peribronchial/hilar lymph nodes (N1) or
             ipsilateral/subcarinal mediastinal lymph nodes (N2)

               -  No N3 lymph nodes (e.g., contralateral mediastinal/hilar or
                  supraclavicular/scalene) by CT scan or positron emission tomography (PET) scan
                  AND mediastinoscopy

               -  No T4 primary tumor (e.g., mediastinal invasion)

          -  No malignant pleural effusion

               -  Nonmalignant effusions (i.e., negative cytology, non-bloody, and transudate)
                  allowed

               -  Effusions visible only by CT scan and not large enough for safe thoracentesis
                  allowed

          -  No exudative effusion, defined by 1 of the following criteria:

               -  Pleural fluid protein:serum protein ratio > 0.5

               -  Pleural fluid lactic dehydrogenase (LDH):serum LDH ratio ≥ 0.6

               -  Pleural fluid LDH > 200 IU/L

          -  No more than 1 area of fludeoxyglucose (FDG) uptake outside the area of the primary
             lung tumor OR evidence of malignant pleural disease as evidenced by pleural nodules by
             PET scan

               -  Single areas of FDG uptake will be further evaluated (e.g., by biopsy) for
                  metastatic disease

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  ECOG 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  WBC ≥ 3,000/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 9 g/dL

        Hepatic

          -  Bilirubin ≤ 1.5 mg/dL

          -  SGOT or SGPT ≤ 1.5 times upper limit of normal

        Renal

          -  Creatinine clearance ≥ 45 mL/min

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 3 months after
             completion of study treatment

          -  No other active malignancy within the past 2 years except nonmelanoma skin cancer or
             carcinoma in situ of the cervix

          -  No psychological, familial, sociological, or geographical situation that would
             preclude study compliance

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  No prior chemotherapy for lung cancer

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  No prior radiotherapy for lung cancer

        Surgery

          -  No prior surgery for lung cancer

          -  At least 12 weeks since prior major surgery to the chest and abdomen

        Other

          -  No concurrent aspirin or other nonsteroidal anti-inflammatory drugs for ≥ 2 days
             before (5 days for drugs with a long half-life [e.g., naproxen, piraoxicam, difunisal,
             nabumetone, rofecoxib, or celecoxib] or 8 days for long acting agents), during, and
             for 2 days after completion of each pemetrexed disodium administration

          -  No concurrent participation in another study involving chemotherapy or radiotherapy