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A Randomized Phase II Trial of Two Different Schedules of Administration of Rebeccamycin Analog in Patients With Advanced Non-Small Cell Lung Cancer
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 which regimen of rebeccamycin analogue is more effective in treating non-small cell lung cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of two rebeccamycin analogue regimens in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.
OBJECTIVES: * Compare the efficacy, in terms of response rate, in patients with advanced or recurrent non-small cell lung cancer treated with rebeccamycin analogue via 1 infusion vs 5 daily infusions every 3 weeks. * Compare the response duration in patients treated with these regimens. * Compare the toxicity profiles of these two regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (0 or 1 vs 2) and participating center. Patients are randomized to one of two treatment arms. * Arm I: Patients receive rebeccamycin analogue IV over 1 hour on day 1. * Arm II: Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment for both arms repeats every 3 weeks for 6-8 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 36-64 patients (18-32 per arm) will be accrued for this study at a rate of 3-4 patients per month.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Henry Ford Hospital
Detroit, Michigan, United States
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Start Date
May 1, 2000
Primary Completion Date
July 1, 2003
Completion Date
January 1, 2005
Last Updated
June 10, 2010
42
ACTUAL participants
becatecarin
DRUG
Lead Sponsor
Case Comprehensive Cancer Center
Collaborators
NCT06498635
NCT06066138
Data Source & Attribution
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