Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: carboplatin; paclitaxel; conventional surgery; radiation therapy
Intervention MeSH terms: Paclitaxel; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer

Summary:

      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
      Giving combination chemotherapy with radiation therapy before and after surgery may shrink
      the tumor so it can be removed during surgery and may kill any remaining tumor cells
      following surgery.

      PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel and carboplatin
      with radiation therapy and surgery in treating patients who have newly diagnosed locally
      advanced non-small cell lung cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed, newly diagnosed, unilateral primary
             non-small cell lung cancer (NSCLC)

               -  Must have involvement of the superior sulcus, chest wall, or mediastinum

          -  Must have at least 1 of the following:

               -  Locally advanced Pancoast tumors with no documented mediastinal or
                  supraclavicular nodal involvement (T3-T4, N0-1)

               -  Resectable chest wall disease (T3, N0-1)

               -  Marginally resectable T4, N0-1, or NX central NSCLC

               -  N2 patients who are potentially resectable after induction chemoradiotherapy

          -  No evidence of extrathoracic spread to liver, adrenals, brain, or bone

          -  No evidence of supraclavicular nodes, malignant pleural or pericardial effusions, or
             distant metastases

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  Karnofsky 70-100%

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count at least 2,000/mm^3

          -  Platelet count at least 100,000/mm^3

        Hepatic

          -  Bilirubin no greater than 1.5 mg/dL

          -  SGOT no greater than 3 times upper limit of normal

        Renal

          -  Creatinine no greater than 2.0 mg/dL

        Cardiovascular

          -  No superior vena cava syndrome

          -  No myocardial infarction within the past 6 months

          -  No active uncontrolled congestive heart failure

          -  No active uncontrolled arrhythmia within the past 6 months

        Pulmonary

          -  FEV1 at least 800 mL

        Other

          -  No other active invasive malignancy requiring therapy within the past 2 years

          -  No ongoing need for adjuvant therapy

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for at least 3 months
             after study entry

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  Not specified

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  No prior pelvic or thoracic radiotherapy

        Surgery

          -  See Disease Characteristics

        Other

          -  Concurrent beta blockers, digitalis derivatives, or channel-blocking agents allowed
             provided cardiac conditions are stable