nitrocamptothecin in treating patients with advanced 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. purpose: phase ii trial to study the effectiveness of nitrocamptothecin in treating patients who have advanced small cell lung cancer.

objectives: * determine the objective response and duration of objective response in patients with advanced small cell lung cancer treated with nitrocamptothecin. * determine the probability of objective response as expressed by the response rate in patients treated with this regimen. * determine the toxicities of this regimen in these patients. outline: this is a multicenter study. patients are stratified according to disease status (sensitive vs refractory). patients receive oral nitrocamptothecin daily for 5 consecutive days each week for 3 weeks. treatment continues every 3 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. patients who achieve stable disease (sd) receive up to 4 additional courses past sd. patients who achieve partial response (pr) or complete response (cr) receive a minimum of 2 additional courses past cr or pr. patients are followed every 6 weeks until disease progression or initiation of another antitumor treatment. projected accrual: a total of 14-25 patients will be accrued for the sensitive disease stratum and a total of 19-24 patients will be accrued for the refractory disease stratum

Eligibility criteria:
disease characteristics: * histologically proven advanced (extensive stage) small cell lung cancer with progressive or recurrent disease after 1 first line chemotherapy regimen * sensitive disease, defined as a response to prior chemotherapy lasting at least 3 months from the end of all prior treatment, including radiotherapy, until the time of progression or * refractory disease, defined as no response to prior chemotherapy, or a response to prior chemotherapy followed by progression within 3 months after completion of all prior therapy, including radiotherapy * minimum of 1 target lesion that can be accurately measured in at least 1 dimension * 20 mm or more with conventional techniques or * 10 mm or more with spiral ct scans * no symptomatic brain metastases patient characteristics: age: * 18 and over performance status: * ecog 0-2 life expectancy: * at least 3 months hematopoietic: * neutrophil count at least 2,000/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * bilirubin less than 1.5 times upper limit of normal (uln) * alkaline phosphatase, sgot, and sgpt no greater than 2.5 time uln (no greater than 5 times uln if hepatic metastases present) renal: * creatinine no greater than 1.7 mg/dl cardiovascular: * no ischemic heart disease within the past 6 months * normal 12 lead electrocardiogram other: * not pregnant or nursing * fertile patients must use effective contraception * no other prior or concurrent malignancy except cone biopsied carcinoma of the cervix or adequately treated basal cell or squamous cell skin cancer * no unstable systemic disease or active uncontrolled infection * no psychological, familial, sociological, or geographical condition that may preclude compliance prior concurrent therapy: biologic therapy: * prior maintenance therapy with biologic agents following first line chemotherapy allowed * no concurrent filgrastim (g-csf) with nitrocamptothecin chemotherapy: * see disease characteristics * greater than 4 weeks since prior chemotherapy * no more than 1 prior chemotherapy regimen for extensive disease * alternate or sequential use of different regimens without interruption in first line treatment is considered 1 first line therapy endocrine therapy: * not specified radiotherapy: * see disease characteristics * greater than 4 weeks since prior radiotherapy surgery: * greater than 2 weeks since prior major surgery other: * no other concurrent anticancer therapy * no other concurrent investigational therapy

Keywords: extensive stage small cell lung cancer recurrent small cell lung cancer