G-CSF and Pegfilgrastim in Treating Neutropenia in Patients Undergoing Radiation Therapy and Chemotherapy for Limited Stage Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: Filgrastim; Pegfilgrastim; Etoposide; Cisplatin; radiation therapy
Intervention description: 5 mcg/kg/day IV (intravenous) days 4-13 and days 25-34 for a total of 20 doses.; 6 mg via subcutaneous injection days 46 and 67; Concurrent: 120 mg/m^2, IV on days 1-3 and days 22-24. Adjuvant: 120 mg/m^2, IV on days 43-45 and days 65-66.; Concurrent: 60 mg/m^2, IV on days 1 and 22. Adjuvant: 60 mg/m^2, IV on days 43 and 64.; A total of 61.2 Gy in 5 weeks: Once-daily 1.8 Gy fractions for 15 fractions over 3 weeks beginning on day 1 of chemotherapy, then twice-daily 1.8 Gy fractions for 10 fractions over 2 weeks.
Intervention MeSH terms: Etoposide
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: limited stage small cell lung cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as cisplatin and etoposide, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Colony-stimulating
      factors, such as G-CSF or pegfilgrastim, may increase the number of immune cells found in
      bone marrow or peripheral blood and may help the immune system recover from the side effects
      of chemotherapy and radiation therapy.

      PURPOSE: This phase II trial is studying G-CSF and pegfilgrastim to see how well they work in
      treating neutropenia in patients undergoing combination chemotherapy and radiation therapy
      for limited stage small cell lung cancer.
    

Eligibility 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 (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