s0004: combination chemotherapy plus 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: phase i trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have limited-stage small cell lung cancer.

objectives: * determine the feasibility of tirapazamine, cisplatin, and etoposide concurrently with radiotherapy in patients with limited stage small cell lung cancer. * determine the toxicities of this treatment regimen in these patients. * determine the response rate in these patients treated with this regimen. outline: patients are assigned to one of two induction therapy arms. * arm i: patients receive induction chemotherapy consisting of low-dose tirapazamine iv over 1 hour and cisplatin iv over 1 hour on days 1, 8, 29, and 36 and etoposide iv over 1 hour on days 1-5 and 29-33. patients also undergo radiotherapy concurrently with chemotherapy 5 consecutive days a week for 7 weeks beginning on day 1. * arm ii: patients receive induction chemotherapy consisting of high-dose tirapazamine, cisplatin, etoposide, and radiotherapy as in arm i. patients with stable or responding disease then receive consolidation therapy consisting of tirapazamine iv over 1 hour and cisplatin iv over 1 hour on day 1 of weeks 11 and 14 and etoposide iv over 1 hour on days 1-3 of weeks 11 and 14. patients are followed every 2 months for 1 year and then every 6 months for 2 years. projected accrual: a total of 50 patients (25 per arm) will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed limited stage small cell lung cancer (sclc) * no malignant pericardial or pleural effusions, including any of the following: * cytologically positive effusions * exudative effusions not attributable to other etiologies * no brain metastases * disease (measurable or non-measurable) must be present outside the area of prior surgical resection patient characteristics: age: * 18 and over performance status: * zubrod 0-1 life expectancy: * not specified hematopoietic: * absolute neutrophil count greater than 1,500/mm\^3 * platelet count greater than 100,000/mm\^3 hepatic: * bilirubin no greater than 1.5 times upper limit of normal (uln) * sgot or sgpt no greater than 2 times uln * alkaline phosphatase no greater than 2 times uln renal: * creatinine no greater than uln or * creatinine clearance at least 60 ml/min other: * not pregnant or nursing * fertile patients must use effective contraception * no symptomatic sensory neuropathy grade 1 or greater * no other malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other stage i or ii cancer in complete remission * no other medical illness that would preclude study participation prior concurrent therapy: biologic therapy: * no prior biologic therapy for sclc chemotherapy: * no prior systemic chemotherapy for sclc endocrine therapy: * not specified radiotherapy: * no prior thoracic radiotherapy for sclc surgery: * see disease characteristics * at least 2 weeks since prior thoracic or other major surgery and recovered

Keywords: limited stage small cell lung cancer