Radiation Therapy, Cisplatin, and Etoposide in Treating Patients With Non-small Cell Lung Cancer That Cannot Be Removed by Surgery

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose (MTD) of escalating doses of radiotherapy (RT)
administered concomitantly with a fixed dose of cisplatin and etoposide within the same
overall treatment time.

OUTLINE: This is a dose-escalation study of radiation therapy.

Patients undergo 3-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated
radiotherapy (IMRT) 5 days a week for 8 weeks. Patients also receive cisplatin intravenously
(IV) over 60 minutes on days 1, 8, 28, and 36 and etoposide IV over 60 minutes on days 1-5
and 28-32.

After completion of study treatment, patients are followed up at 8 weeks and 6 months.

Inclusion Criteria:

- Patients with confirmed unresectable Stage IIB or Stage III non-small cell lung
cancer of any histologic-subtype appropriate for definitive concurrent chemotherapy
and radiation as determined by multi-disciplinary assessment; all detectable tumor
should be encompassable by radiation therapy fields, including both the primary tumor
and the involved regional lymph nodes

- Granulocytes >= 1500/ul

- Platelets >= 100,000/ul

- Bilirubin < 1.5 mg/dl

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) < 2
upper limit of normal (ULN)

- Creatinine clearance must be > 60ml/min

- Eastern Cooperative Oncology Group (ECOG) 0 to 1

- Weight loss =< 5% in the previous six months unless weight loss is intentional (per
judgment of study medical doctor [MD])

- Forced expiratory volume in one second (FEV1) must be >= 1.0 L

- Patients must sign a study-specific informed consent form prior to study entry

- Patients must have measurable disease on the 3D planning computed tomography (CT)

- Patient must have a completed 3D plan and the attending physician must have reviewed
and approved the dose volume histograms as follows: total lung volume percentage
receiving at least 20 Gy (V20) =< 35%, and mean lung dose =< 20 Gy

Exclusion Criteria:

- Mixed histology or undifferentiated small cell carcinoma, any stage

- Concurrent malignancy except non-melanomatous skin cancer or prior cancer if
disease-free for one year or more

- Patients with malignant pleural effusions or significant pericardial effusions

- Pregnant or lactating females

- Severe neuropathy greater than or equal to grade 2

- Severe sensorineural hearing loss greater or equal to grade 2

- No clinically significant history of cardiac disease, (i.e. uncontrolled
hypertension, unstable angina, congestive heart failure, myocardial infarction within
the past year, or cardiac ventricular arrhythmias requiring medication)

- Any significant or severe medical conditions or psychiatric or social conditions that
would preclude adherence to the protocol or compliance with study treatments