Lung Cancer Clinical Trial
Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if topotecan is more effective given by infusion or by mouth.
PURPOSE: Randomized phase III trial to compare the effectiveness of topotecan given by infusion with that of topotecan given by mouth in treating patients who have small cell lung cancer that has relapsed following previous therapy.
Full Description
OBJECTIVES: I. Compare the response rate, response duration, time to response, time to progression, and survival of patients with relapsed limited or extensive stage small cell lung cancer treated with oral vs intravenous topotecan. II. Compare the qualitative and quantitative toxicities of these treatment regimens in this patient population. III. Compare the quality of life in these patients.
OUTLINE: This is randomized, multicenter study. Patients are stratified according to gender, liver metastases (yes vs no), and duration of response to prior chemotherapy (6 months or less vs greater than 6 months). Patients are randomized to one of two treatment arms. Arm I: Patients receive topotecan IV over 30 minutes on days 1-5. Arm II: Patients receive topotecan orally on days 1-5. Treatment repeats every 3 weeks in the absence of unacceptable toxicity. Patients experiencing complete or partial response continue until progression or for at least 2 courses past maximal response. Patients with stable disease should receive at least 4 courses. Quality of life is assessed Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed limited or extensive stage small cell lung cancer (SCLC) Disease recurring at least 90 days following completion of first line chemotherapy Partial or complete response to first line therapy Must have at least one bidimensionally measurable non CNS lesion May be within a prior radiation port if at least 6 weeks since prior radiotherapy and progressing Brain and/or leptomeningeal metastases allowed if asymptomatic and not requiring corticosteroids
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 2 months Hematopoietic: WBC at least 3,500/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL (after transfusion, if needed) Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT and SGPT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Alkaline phosphatase no greater than 2 times ULN (no greater than 5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: No active uncontrolled infection No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I low grade prostate cancer No other severe medical conditions that would preclude study or cause exposure to extreme risk or decreased life expectancy No uncontrolled emesis No active peptic ulcer, diabetes mellitus, chronic gastritis, significant ascites, or other gastrointestinal (GI) conditions (e.g., removal of a portion of the stomach or recent GI obstruction) that would alter absorption or GI motility No history of allergic reactions to compounds chemically related to topotecan Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for 3 months prior to, during, and at least 4 weeks after the study
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 months since prior immunotherapy No concurrent immunotherapy for SCLC Chemotherapy: See Disease Characteristics No prior topotecan Only one prior chemotherapy regimen allowed No other concurrent chemotherapy for SCLC Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics At least 24 hours since prior radiotherapy No concurrent radiotherapy for SCLC Surgery: At least 4 weeks since prior surgery Other: At least 30 days or five half lives since other prior investigational drugs No prior drugs (e.g., cisapride) that would alter absorption or GI motility No other concurrent investigational therapy for SCLC
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There are 53 Locations for this study
Birmingham Alabama, 35294, United States
Phoenix Arizona, 85012, United States
Bakersfield California, 93309, United States
Fountain Valley California, 92708, United States
La Jolla California, 92037, United States
Los Angeles California, 90073, United States
Poway California, 92064, United States
Sacramento California, 95817, United States
San Diego California, 92120, United States
San Diego California, 92121, United States
Colorado Springs Colorado, 80909, United States
Gainesville Florida, 32610, United States
Jacksonville Florida, 32207, United States
Miami Florida, 33176, United States
Pensacola Florida, 32522, United States
Tampa Florida, 33612, United States
Augusta Georgia, 30912, United States
Evanston Illinois, 60201, United States
Hines Illinois, 60141, United States
Indianapolis Indiana, 46219, United States
Lafayette Louisiana, 70506, United States
New Orleans Louisiana, 70121, United States
Detroit Michigan, 48202, United States
Pontiac Michigan, 48341, United States
Saint Louis Park Minnesota, 55416, United States
Saint Louis Missouri, 63141, United States
Camden New Jersey, 08103, United States
Livingston New Jersey, 07039, United States
Voorhees New Jersey, 08043, United States
Santa Fe New Mexico, 87505, United States
Rochester New York, 14621, United States
Syracuse New York, 13210, United States
Winston-Salem North Carolina, 27103, United States
Winston-Salem North Carolina, 27157, United States
Cleveland Ohio, 44106, United States
Hershey Pennsylvania, 17033, United States
Lemoyne Pennsylvania, 17043, United States
Pittsburgh Pennsylvania, 15213, United States
Reading Pennsylvania, 19612, United States
Providence Rhode Island, 02912, United States
Greenville South Carolina, 29605, United States
Spartanburg South Carolina, 29303, United States
Knoxville Tennessee, 37901, United States
Nashville Tennessee, 37203, United States
Fort Worth Texas, 76104, United States
Galveston Texas, 77555, United States
Houston Texas, 77030, United States
Lubbock Texas, 79410, United States
Temple Texas, 76508, United States
Norfolk Virginia, 23502, United States
Richmond Virginia, 23226, United States
Roanoke Virginia, 24014, United States
Waukesha Wisconsin, 53188, United States
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