Phase II Trial of XL119 (Rebeccamycin Analogue) in Relapsed "Sensitive" Small Cell Lung Cancer
I. Determine the objective response rate in patients with limited or extensive stage small
cell lung cancer that relapsed after prior first-line chemotherapy when treated with
rebeccamycin analogue as second-line therapy.
II. Determine the duration of remission and survival of patients treated with this drug.
III. Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every
21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed annually.
PROJECTED ACCRUAL: A total of 20-39 patients will be accrued for this study within 15
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate estimated as the proportion of responders
An exact binomial 95% confidence interval will be calculated for this proportion.
Up to 4 years
Case Western Reserve University
United States: Food and Drug Administration
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