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The Use Of Weekly Topotecan As Second Line Therapy In Small Cell Lung Cancer
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States
Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Start Date
April 1, 2004
Primary Completion Date
February 1, 2006
Completion Date
February 1, 2006
Last Updated
March 22, 2016
1
ACTUAL participants
topotecan hydrochloride
DRUG
Lead Sponsor
Case Comprehensive Cancer Center
Collaborators
NCT07336732
NCT06066138
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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