Lung Cancer
Conditions
Keywords
extensive stage small cell lung cancer, recurrent small cell lung cancer
Brief 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.
Detailed description
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
Interventions
Sponsors
Study design
Eligibility
Inclusion 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
Countries
France