Liposomal SN-38 in Treating Patients With Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as liposomal SN-38, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well liposomal SN-38 works in treating patients with small cell lung cancer.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Liposome Encapsulated SN38 (LE-SN38) in the Treatment of Small Cell Lung Cancer|
- Tumor response measured by number of responses [ Designated as safety issue: No ]
- Time to disease progression [ Designated as safety issue: No ]
- Survival time [ Designated as safety issue: No ]
- Change in quality of life (QOL) score over time [ Designated as safety issue: No ]
- Association between change in QOL score and response, toxicity, and other variables [ Designated as safety issue: Yes ]
- 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 prior treatment).
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 3 years.
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.
|Study Chair:||James R. Jett, MD||Mayo Clinic|
|Investigator:||Marie C. Aubry, MD||Mayo Clinic|
|Investigator:||Matthew M. Ames, PhD||Mayo Clinic|
|Investigator:||Matthew P. Goetz, MD||Mayo Clinic|