A Phase II Trial of Combined Modality Therapy With Growth Factor Support for Patients With Limited Stage Small Cell Lung Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed small cell carcinoma of the lung

- Limited stage disease, defined as any of the following:

- Tumor confined to one hemithorax

- T4 tumor not based on malignant pleural effusion

- N3 disease not based on contralateral supraclavicular involvement

- No complete tumor resection

- Measurable or evaluable disease

- Pleural effusion allowed provided the following conditions are present:

- Effusion is too small to tap under CT guidance and is not evident on chest x-ray

- Effusion appears only after a thoracotomy or other invasive procedure

- Must have certification by a Radiation Oncologist that the tumor can be encompassed
by limited radiotherapy fields without significantly compromising pulmonary function

- No distant metastases

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-1

- ANC ≥ 1,800 cells/mm³

- Platelet count ≥ 100,000 cells/mm³

- Hemoglobin ≥ 10.0 g/dL (transfusion or other intervention to achieve hemoglobin ≥ 8.0
g/dL allowed)

- Total bilirubin ≤ 1.5 mg/dL

- AST or ALT ≤ 2 times the upper limit of normal (ULN)

- Alkaline phosphatase < 2.5 times ULN (< 5 times ULN if judged by the investigator to
be related to liver metastases)

- Creatinine ≤ 1.5 mg/dL

- Creatinine clearance ≥ 50 mL/min

- Must have best value of FEV1 ≥ 1.5 liters/second obtained on two measurements taken
before and after use of a bronchodilator

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for ≥ 60 days after the
last study treatment

- No prior invasive malignancy, except non-melanomatous skin cancer or other
micro-invasive malignancy, or carcinoma in situ of the breast, oral cavity, or
cervix, unless the patient has been disease-free for a minimum of 3 years

- No weight loss > 5% for any reason within the past 3 months

- No severe, active comorbidity, defined as follows:

- Unstable angina and/or congestive heart failure requiring hospitalization within
the past 6 months

- Transmural myocardial infarction within the past 6 months

- Acute bacterial or fungal infection requiring intravenous antibiotics

- Chronic Obstructive Pulmonary Disease exacerbation with FEV1 < 1.5 liters/second
or other respiratory illness requiring hospitalization or precluding study
therapy within the past 30 days

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

- AIDS

- No prior allergic reaction to the study drugs

PRIOR CONCURRENT THERAPY:

- No prior systemic chemotherapy for lung cancer

- Prior chemotherapy for a different cancer is allowed, provided it was completed
≥ 5 years prior to registration

- No prior radiotherapy to the region of the study cancer that would result in overlap
of radiotherapy fields

- No concurrent intensity-modulated radiotherapy

- No concurrent amifostine