Phase II Trial of XL119 (Rebeccamycin Analogue) in Relapsed "Sensitive" Small Cell Lung Cancer
OBJECTIVES:
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
months.
Interventional
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
No
Afshin Dowlati
Principal Investigator
Case Western Reserve University
United States: Food and Drug Administration
NCI-2012-02587
NCT00084487
April 2004
Name | Location |
---|---|
Case Western Reserve University | Cleveland, Ohio 44106 |