A Pilot (Phase I) Study of Weekly Docetaxel and Cetuximab Chemoradiation for Poor Risk Stage III Non-Small Cell Lung Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically proven newly diagnosed single, primary, bronchogenic
stage IIIA or selected stage IIIB (excluding malignant pleural effusion) non-small
cell lung cancer (NSCLC) of one of the following cellular types:

- Adenocarcinoma

- Large cell carcinoma

- Squamous cell carcinoma

- Unspecified

- Histology or cytology from involved mediastinal or supraclavicular nodes will be
sufficient for diagnosis if a separate primary lesion of the lung parenchyma is
clearly evident on radiographs (i.e., a second biopsy will not be required)

- Underwent positron emission tomography (PET) scan within the past 42 days

- N2 or N3 mediastinal disease by PET scan OR enlarged nodes on CT scan determined
to be N2 or N3 by biopsy

- Measurable disease, defined as lesions that can be accurately measured in at least
one dimension as ≥ 2 cm by conventional techniques or ≥ 1 cm by spiral CT scan

- Pleural effusion, ascites, bone lesions, and laboratory parameters are not
considered measurable disease

- No brain metastases

- Malignant pleural effusion allowed provided 1 of the following is true:

- Present before mediastinoscopy or exploratory thoracotomy AND the pleural fluid
is transudate with negative cytology

- Present only after but not before exploratory or staging thoracotomy AND the
pleural fluid is either transudate or exudate with negative cytology

- Present only on CT scan but not on decubitus chest x-ray AND deemed too small to
tap under either CT scan or ultrasound guidance

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-1, meeting ≥ 1 of the following criteria OR Zubrod
performance status 2 with no co-morbidities or meeting 1 of the following criteria:

- No co-morbidities

- FEV_1 < 2 L OR < 1 L with estimated contralateral FEV_1 ≥ 0.6 L

- DLCO > 10 mL/mm Hg/min

- Albumin < 0.85 times lower limit of normal

- Unintentional weight loss > 10% within the past 6 months

- Controlled congestive heart failure which, in the opinion of the investigator,
may become decompensated due to radiotherapy

- FEV_1 < 2 L OR < 1 L with estimated contralateral FEV_1 ≥ 0.6 L

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Serum creatinine ≤ 1.5 times upper limit of normal (ULN)

- Must provide prior smoking history

- Serum bilirubin normal

- Meets one of the following criteria:

- Alkaline phosphatase (AP) ≤ 4 times ULN AND SGOT or SGPT normal

- AP normal AND SGOT or SGPT ≤ 2.5 times ULN

- No other prior malignancy within the past 5 years except adequately treated basal
cell or squamous cell skin cancer, in situ cervical cancer, or adequately treated
stage I or II cancer from which the patient is currently in complete remission

- No pregnant or nursing patients

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

- No prior chemotherapy or curative surgery for this cancer

- No prior radiotherapy to the neck and/or thorax for any reason

- No prior therapy which specifically targets the EGFR pathway

- No concurrent growth factors (e.g., filgrastim [G-CSF], epoetin alfa, or
pegfilgrastim) or amifostine

- No concurrent intensity-modulated radiotherapy

- No concurrent prophylactic mediastinal, contralateral hilar, or supraclavicular lymph
node radiotherapy