Phase II Trial of Liposome Encapsulated SN38 (LE-SN38) in the Treatment of Small Cell Lung Cancer
- Determine the response rate in patients with small cell lung cancer treated with SN-38
liposome that is dosed according to a UGT1A1-specific genotype.
- Determine the toxicity of this drug in these patients.
- Determine, preliminarily, overall and progression-free survival of patients treated
with this drug.
- Determine the quality of life of patients treated with this drug.
- Correlate UGT1A1-specific haplotypes with toxicity of this drug in these patients.
- Correlate UGT1A1-specific haplotypes with outcomes of patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to length of time
since prior treatment (previously untreated disease OR chemosensitive disease and ≥ 3 months
since prior treatment vs refractory disease OR chemoresistant disease and < 3 months since
Patients receive SN-38 liposome IV over 90 minutes on day 1. Treatment repeats every 21 days
for 2 courses in the absence of disease progression or unacceptable toxicity. Patients
achieving a complete or partial response or patients with stable disease (SD) who were
previously treated before study enrollment receive up to 4 additional courses of treatment.
Patients with CNS-only disease progression receive whole brain radiotherapy (WBRT). After
completion of WBRT, these patients also receive up to 4 additional courses of treatment.
Patients with disease progression to sites other than the CNS or patients with SD who were
previously untreated before study enrollment are removed from the study.
Quality of life is assessed at baseline, before each treatment course, and then annually for
After completion of study treatment, patients are followed every 3 months for 1 year and
then every 6 months for 2 years.
PROJECTED ACCRUAL: Approximately 73 patients (40 for stratum I and 33 for stratum II) will
be accrued for this study within 16-19 months.
Masking: Open Label, Primary Purpose: Treatment
Tumor response measured by number of responses
James R. Jett, MD
United States: Federal Government