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
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the pathologic complete response in patients with stage IB-IIIB non-small cell
           lung cancer treated with neoadjuvant chemotherapy comprising pemetrexed disodium and
           cisplatin followed by surgery and adjuvant pemetrexed disodium and cisplatin.

      Secondary

        -  Determine the adverse events of this regimen in these patients.

        -  Determine the overall and disease-free survival of patients treated with this regimen.

        -  Correlate response with the presence or absence of ERCC1 and DHFR, thymidylate synthase,
           DPD, and GARFT in patients treated with this regimen.

        -  Correlate the fragile site on chromosome 12 within the SMRT gene with metastasis after
           definitive treatment with this regimen in these patients.

      OUTLINE:

        -  Neoadjuvant chemotherapy: Patients receive pemetrexed disodium IV over 10 minutes
           followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21
           days for 3 courses. Patients are then evaluated for disease resectability. Patients with
           no evidence of disease progression proceed to thoracotomy within the next 28-48 days.

        -  Thoracotomy: Patients found to have unresectable disease during thoracotomy receive
           further treatment off study. Patients with resectable disease undergo complete surgical
           resection of the tumor. Forty to eighty days later, patients proceed to adjuvant
           chemotherapy.

        -  Adjuvant chemotherapy: Patients receive pemetrexed disodium and cisplatin as before for
           2 courses.

      Patients with progressive disease after completion of neoadjuvant chemotherapy are followed
      every 6 months. All other patients are followed every 3 months for 2 years, every 6 months
      for 3 years, and then annually thereafter.

      PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study over 6.5 years.
    

Intervention name(s): cisplatin; pemetrexed disodium; adjuvant therapy; conventional surgery; neoadjuvant therapy
Intervention type(s): Drug; Drug; Procedure; Procedure; Procedure
Intervention description(s): Given IV; Given IV; Metastasis prevention/control; Undergoing tissue removal; Tumor Reduction
Intervention MeSH terms: Pemetrexed
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
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