topotecan in treating patients with recurrent extensive-stage small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. purpose: this phase ii trial is studying how well high-dose topotecan works as second-line therapy in treating patients with recurrent extensive-stage small cell lung cancer.

objectives: primary * determine the overall survival of patients with recurrent extensive stage small cell lung cancer treated with high-dose topotecan hydrochloride. secondary * determine the safety and toxic effects of this drug in these patients. * determine the recurrence-free survival of patients treated with this drug. * determine time to response and tumor response in patients treated with this drug. * determine the quality of life of patients treated with this drug. outline: this is a non-randomized, multicenter study. patients receive high-dose topotecan hydrochloride iv over 30 minutes on days 1, 8, 15, 22, 29, and 36. treatment repeats every 56 days for 4 courses in the absence of disease progression or unacceptable toxicity. quality of life is assessed at baseline, day 1 of each course (except course 1), at the end of study treatment, and then every 3 months thereafter. patients are followed at 7-14 days and then every 3 months thereafter. projected accrual: a total of 65 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed small cell lung cancer (sclc) * recurrent extensive stage disease * no mixed histology * measurable disease * at least 1 bidimensionally measurable, non-central nervous system (cns), indicator lesion confirmed by ct scan or mri * sensitive disease * responded to prior first-line therapy and relapsed ≥ 60 days after response (90 days after initiation of first-line therapy) * eligible for high-dose chemotherapy * no symptomatic brain metastases affecting performance status patient characteristics: age * 18 and over performance status * eastern cooperative oncology group (ecog) 0-2 life expectancy * at least 2 months hematopoietic * absolute neutrophil count ≥ 1,500/mm\^3 * platelet count ≥ 100,000/mm\^3 * hemoglobin ≥ 9.0 g/dl * hematocrit \> 35% (without transfusion) hepatic * serum glutamic-oxaloacetic transaminase (sgot) and serum glutamate pyruvate transaminase (sgpt) ≤ 2 times normal\* * alkaline phosphatase ≤ 2 times normal\* * bilirubin ≤ 2.0 mg/dl * albumin \> 2.5 g/dl * hepatitis b surface antigen negative * no significant hepatic disease note: \*≤ 5 times upper limit of normal if liver metastases are present renal * creatinine clearance ≥ 40 ml/min cardiovascular * no history of cardiac arrhythmias * no congestive heart failure * no ischemic heart disease * no stroke or other embolic disease requiring daily treatment that would preclude study participation other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for 3 months after study participation * hiv negative * no known seizure disorder * no active infection requiring systemic therapy within the past 2 weeks * no known hypersensitivity to topotecan hydrochloride * no medical or psychiatric condition that would preclude study participation * no other malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage a low-grade prostate cancer prior concurrent therapy: biologic therapy * not specified chemotherapy * see disease characteristics * more than 4 weeks since prior antineoplastic and/or myelosuppressive chemotherapy * no more than 1 prior chemotherapy regimen (except for adjuvant chemotherapy) for sclc * no prior topotecan hydrochloride endocrine therapy * not specified radiotherapy * not specified surgery * not specified other * more than 2 months since prior investigational agent * no other concurrent investigational agent

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