combination chemotherapy with or without filgrastim in treating patients with previously untreated extensive-stage small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. purpose: phase ii trial to compare the effectiveness of combination chemotherapy with or without filgrastim in treating patients who have extensive-stage small cell lung cancer that has not been previously treated.

objectives: * determine the tolerability of topotecan and carboplatin with or without filgrastim (g-csf) in patients with extensive stage small cell lung cancer. * determine response and survival rates in patients treated with these regimens. outline: this is a multicenter study. the first 12 patients are assigned to 1 of 2 treatment regimens (6 per regimen). the next 33 patients receive treatment based on the toxicity experienced by the first 12. regimen a: * patients receive oral topotecan once daily on days 1-5, carboplatin iv over 30 minutes on day 5, and filgrastim (g-csf) subcutaneously once daily beginning on day 6 or 7 and continuing for up to 10 days or until blood counts recover. * patients are evaluated after the first 3-week course of chemotherapy. if no patient experiences unacceptable toxicity or febrile neutropenia, or no more than 1 patient experiences an absolute neutrophil count of less than 500/mm3 for more than 5 days, the next 6 patients begin treatment on regimen b. otherwise, all patients receive treatment as in regimen a. regimen b: * patients receive topotecan and carboplatin as in regimen a. * patients are evaluated after the first 3-week course of chemotherapy. if no patient experiences unacceptable toxicity or febrile neutropenia, the next 33 patients receive treatment as in regimen b; otherwise, patients receive treatment as in regimen a. treatment for all patients repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. patients with disease progression limited to cns only interrupt chemotherapy to have whole-brain radiotherapy (wbrt). once wbrt is complete, chemotherapy resumes. quality of life is assessed at baseline and at the beginning of each course of chemotherapy. patients are followed every 3 months for 2 years and then every 6 months for 3 years. projected accrual: a total of 49 patients will be accrued for this study within 13.5 months.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed extensive stage small cell lung cancer * previously untreated with chemotherapy * no mixed histology * metastatic disease outside the chest * contralateral supraclavicular or hilar nodes that cannot be included in a single radiation port or * cytologically proven malignant pleural effusion * measurable disease * no untreated cns metastases * cns metastases treated with whole-brain radiotherapy (wbrt) allowed after completion of wbrt patient characteristics: age: * 18 and over performance status: * ecog 0-2 life expectancy: * not specified hematopoietic: * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * ast no greater than 5 times upper limit of normal (uln) * alkaline phosphatase no greater than 5 times uln * bilirubin no greater than 1.5 times uln or * direct bilirubin no greater than uln renal: * creatinine no greater than 1.5 times uln or * creatinine clearance at least 50 ml/min cardiovascular: * no uncontrolled angina pectoris * no congestive heart failure within the past 3 months unless ejection fraction is greater than 40% * no uncontrolled cardiac arrhythmias * no myocardial infarction within the past 3 months other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no clinically significant infection * no hypersensitivity to e. coli-derived proteins * no other malignancy within the past 3 years except non-melanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer prior concurrent therapy: biologic therapy: * not specified chemotherapy: * see disease characteristics * at least 5 years since prior chemotherapy for another malignancy * no prior nitrosoureas endocrine therapy: * not specified radiotherapy: * see disease characteristics * no prior thoracic radiotherapy * at least 1 day since prior palliative radiotherapy (except to chest) * no more than 3 fractions to chest for superior vena cava syndrome allowed * no concurrent radiotherapy (including thoracic radiotherapy) surgery: * more than 3 weeks since prior major surgery

Keywords: extensive stage small cell lung cancer