G-CSF and Pegfilgrastim in Treating Neutropenia in Patients Undergoing Radiation Therapy and Chemotherapy for Limited Stage Small Cell Lung Cancer

OBJECTIVES:

Primary

• To evaluate the safety and efficacy of filgrastim (G-CSF) in reducing grade 4 neutropenia or grades 3-4 febrile neutropenia in patients with limited stage small cell lung cancer treated with radiotherapy and concurrent chemotherapy comprising cisplatin and etoposide.

Secondary

• To evaluate the safety and efficacy of pegfilgrastim in reducing grade 4 neutropenia or grades 3-4 febrile neutropenia in patients treated with adjuvant chemotherapy comprising cisplatin and etoposide.
• To estimate the incidence of dose modifications or treatment delays in patients treated with this regimen.
• To estimate the incidence of esophagitis, pneumonitis, and other non-hematological adverse events in patients treated with this regimen.
• To estimate the incidence of grade 4 thrombocytopenia in patients treated with this regimen.
• To estimate the median and two-year rate of progression-free and overall survival of patients treated with this regimen.

After completion of study therapy, patients are followed every 3 months for one year, every 6 months for 2-3 years, and then annually for up to 5 years.

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 (absolute neutrophil count) ≥ 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 (aspartate aminotransferase) or ALT (alanine amino transferase ) ≤ 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)
• Serum creatinine ≤ 1.5 mg/dL
• Creatinine clearance ≥ 50 mL/min
• FEV1 (Forced Expiratory Volume) obtained pre- or post-bronchodilator must be ≥ 1.5 liters/second
• 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 (forced expiratory volume) < 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 (HIV testing not required for entry into this protocol)
• 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