Carboplatin, Paclitaxel, Selenomethionine, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: selenomethionine; carboplatin; paclitaxel; laboratory biomarker analysis; radiation therapy
Intervention description: Oral Twice daily; Weekly IV; Weekly IV; Correlative Study; Undergoing radiation Therapy
Intervention MeSH terms: Selenium; Paclitaxel; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: squamous cell lung cancer; adenocarcinoma of the lung; bronchoalveolar cell lung cancer; large cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; adenosquamous cell lung cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Selenomethionine may slow the growth of tumor cells. Radiation therapy uses
      high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with
      selenomethionine and radiation therapy may kill more tumor cells.

      PURPOSE: This phase II trial is studying the side effects and how well selenomethionine works
      when given together with carboplatin, paclitaxel, and radiation therapy in treating patients
      with stage III non-small cell lung cancer that cannot be removed by surgery.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed non-small cell lung cancer (NSCLC),
             including any of the following histologic subtypes:

               -  Squamous cell carcinoma

               -  Adenocarcinoma (including bronchoalveolar cell carcinoma)

               -  Large cell anaplastic carcinoma (including giant and clear cell carcinoma)

          -  Stage IIIA disease OR selected stage IIIB disease

               -  T1-2, N2 disease OR T3, N2 or T4, N0-N2 disease (if based on tumor closeness to
                  the carina, invasion of the mediastinum, or invasion of the chest wall)

                    -  Contralateral mediastinal disease (N3) allowed if all gross disease can be
                       encompassed in the radiation boost field

          -  Tumors adjacent to a vertebral body allowed unless there is demonstrable bone invasion

               -  All gross disease must be able to be encompassed in the radiation boost field

               -  No direct invasion of a vertebrae body

          -  Unresectable or inoperable disease

          -  Measurable disease

          -  Suitable for radiotherapy, as deemed by the radiation oncologist

          -  No scalene, supraclavicular, or contralateral hilar node involvement

          -  Pleural effusion allowed provided it is transudate, cytologically negative, and
             non-bloody, and, according to the radiation oncologist, the tumor can be encompassed
             within a reasonable radiation field

               -  Pleural effusion seen on chest CT scan, but not on chest x-ray, that is too small
                  to tap is allowed

               -  No exudative, bloody, or cytologically malignant effusions

          -  No known brain metastases

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  ANC ≥ 1,500/mm³

          -  Platelet count ≥ 75,000/mm³

          -  Total bilirubin ≤ 1.5 mg/dL

          -  Creatinine normal

          -  Alkaline phosphatase AND AST or ALT meeting 1 of the following criteria:

               -  Alkaline phosphatase normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)

               -  Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN

               -  Alkaline phosphatase ≤ 5 times ULN AND AST or ALT normal

          -  Able to swallow oral medications

          -  No peripheral neuropathy > grade 1

          -  No history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to selenomethionine or agents formulated with Cremophor EL

          -  No concurrent uncontrolled illness including, but not limited to, any of the
             following:

               -  Ongoing or active infection

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Clinically significant cardiac arrhythmia

               -  Psychiatric illness or social situations that would limit compliance with study
                  requirements

          -  No currently "active" second malignancy other than non-melanoma skin cancer

               -  Patients are considered not to have an "active" malignancy if they have completed
                  therapy and are considered by their physician to be at less than 30% risk of
                  relapse

          -  Not pregnant

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

          -  At least 2 weeks since prior formal exploratory thoracotomy (N2 node identified making
             patient ineligible for surgery)

          -  No prior chemotherapy or radiotherapy for NSCLC

          -  No prior taxanes or platinum drugs

          -  No other concurrent investigational agents or anticancer therapy

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No other concurrent chemotherapy or hormonal therapy, except for the following:

               -  Steroids administered for adrenal failure or septic shock

               -  Hormones administered for non-disease-related conditions (e.g., insulin for
                  diabetes)

               -  Glucocorticosteroids administered as antiemetics