Clinical trial NCT00526890 (phase 2, status: terminated)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: carboplatin, paclitaxel
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O, [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC
Reason stopped: 
    lack of efficacy
  
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