Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination With Radiation for Patients With Unresectable Stage III Non-Small Cell Lung Cancer: A Phase II, Multi-Center Trial

Inclusion 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