cisplatin, etoposide, and radiation therapy in treating patients with limited-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. radiation therapy uses high-energy x-rays to damage tumor cells. combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. purpose: this phase ii trial is studying how well giving cisplatin and etoposide together with radiation therapy works in treating patients with limited-stage small cell lung cancer.

objectives: * determine the response rate of patients with limited stage small cell lung cancer treated with cisplatin and etoposide combined with accelerated high-dose thoracic radiotherapy. * determine the progression-free and overall survival in patients treated with this regimen. * determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients. outline: patients undergo radiotherapy once daily 5 days a week for approximately 3 weeks and then twice daily 5 days a week for approximately 2 weeks (a total of 9 treatment days during the final 2-week treatment period). beginning on the first day of radiotherapy, patients receive cisplatin iv over 2 hours and etoposide iv over 1 hour on day 1 and oral etoposide once daily on days 2 and 3. chemotherapy repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. projected accrual: a total of 71 patients will be accrued for this study within 18 months.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed small cell carcinoma of the lung by fine needle aspiration biopsy or two positive sputa * must have limited disease * stage i, ii, iiia, or iiib * confined to 1 hemithorax, but excluding the following: * t4 tumor based on malignant pleural effusion * n3 disease based on contralateral hilar or contralateral supraclavicular involvement * no pericardial or pleural effusions on chest x-ray (regardless of cytology) * measurable or evaluable disease * tumor must be able to be encompassed by limited radiotherapy fields without significantly compromising pulmonary function * no prior complete tumor resection patient characteristics: age * 18 to 100 performance status * zubrod 0-1 life expectancy * not specified hematopoietic * absolute granulocyte count at least 1,500/mm\^3 * platelet count at least 150,000/mm\^3 hepatic * bilirubin no greater than 1.5 mg/dl renal * creatinine no greater than 1.5 mg/dl cardiovascular * no myocardial infarction within the past 6 months * no symptomatic heart disease pulmonary * no chronic obstructive pulmonary disease with forced expiratory volume (fev)-1 no greater than 0.8 liter * no uncontrolled bronchospasm in the unaffected lung other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * available for follow-up * no other malignancy within the past 2 years except curatively treated basal cell or squamous cell skin cancer or non-invasive in situ malignancies * no other concurrent serious medical illness * no uncontrolled psychiatric illness * no chronic alcohol or drug abuse prior concurrent therapy: biologic therapy * not specified chemotherapy * no prior chemotherapy endocrine therapy * not specified radiotherapy * no prior radiotherapy to the chest or other area containing a large amount of bone marrow (e.g., more than 75% of pelvic bone) surgery * see disease characteristics

Keywords: limited stage small cell lung cancer