Carboplatin, Gemcitabine, and Thalidomide in Patients Undergoing Surgery for Stage II or III Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: carboplatin; gemcitabine hydrochloride; thalidomide; conventional surgery
Intervention description: Day 1 of Cycles 1, 2 and 3 - intravenously (IV) 30 minutes (Area Under the Curve = 5.5); Days 1 and 8 of Cycles 1, 2 and 3 - 30 minute IV, 1000 mg/m2.; Oral administration: Cycle 1 - Day 1 50 mg, Day 2 100 mg, Day 3 150 mg, Day 4 and continuing until end of study treatment 200 mg.; Resection - between 2 and 6 weeks following last dose of chemotherapy.
Intervention MeSH terms: Thalidomide; Carboplatin; Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the lung; squamous cell lung cancer; large cell lung cancer; stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Thalidomide may stop the growth of tumor cells by blocking blood flow to the tumor.
      Giving carboplatin and gemcitabine together with thalidomide before surgery may make the
      tumor smaller and reduce the amount of normal tissue that needs to be removed.

      PURPOSE: This phase II trial is studying how well giving carboplatin and gemcitabine together
      with thalidomide works in treating patients who are undergoing surgery for stage II or stage
      III non-small cell lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed non-small cell lung cancer (NSCLC),
             including any of the following histologic subtypes:

               -  Squamous cell carcinoma

               -  Adenocarcinoma

               -  Large cell undifferentiated carcinoma

          -  Stage II or IIIA disease

          -  Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
             conventional techniques OR ≥ 10 mm by spiral Computerized Axial Tomography (CT) scan

          -  No tumor involving the superior sulcus (e.g., Pancoast tumor)

          -  Karnofsky performance status 70-100%

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Creatinine ≤ 2 mg/dL

          -  Bilirubin < 2 mg/dL

          -  Aspartate aminotransferase (AST) < 3 times upper limit of normal

        Exclusion Criteria:

          -  Pregnant or nursing

               -  No nursing during and for ≥ 4 weeks after completion of study treatment

          -  Positive pregnancy test

          -  Fertile female patients must use 2 effective methods of contraception 4 weeks before,
             during, and for 4 weeks after completion of study treatment

          -  Fertile male patients must use effective barrier contraception during and for 4 weeks
             after completion of study treatment

          -  Blood, sperm, or ova donation during study treatment

          -  Post obstructive pneumonia

          -  Other serious infection or medical illness that would preclude study participation

          -  Other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer, carcinoma in situ of the cervix, or other malignancy that
             is unlikely to affect survival for the next 3 years

          -  Less than 5 years since prior resection of lung disease

          -  Prior systemic chemotherapy or radiotherapy for non-small cell lung cancer (NSCLC)

          -  Other concurrent chemotherapy or radiotherapy

          -  Concurrent hormonal therapy or immunotherapy

          -  Other concurrent anticancer therapy

          -  Other concurrent investigational agents

          -  Concurrent participation in another clinical study