Overview
Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer
Status:
Completed
Completed
Trial end date:
2001-11-01
2001-11-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Case Comprehensive Cancer CenterCollaborator:
Smith Kline BeechamTreatments:
Topotecan
Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed limited or extensivestage 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