Phase I Study of Weekly Irinotecan Combined With Amrubicin in Previously Treated Small-Cell Lung Cancer
- Determine the dose-limiting toxicity and maximum tolerated dose of amrubicin when
combined with irinotecan in patients with recurrent or relapsed extensive stage small
cell lung cancer.
- Determine the response rate in patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
- Determine the frequency and severity of adverse events in patients treated with this
OUTLINE: This is a dose-escalation study of amrubicin.
Patients receive amrubicin on day 1 and irinotecan IV on days 1 and 8. Courses repeat every
21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of up to 6 patients receive escalating doses of amrubicin until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which
at least 1/3 (or 33%) of patients experience dose-limiting toxicity. An additional 6
patients are treated at the MTD.
PROJECTED ACCRUAL: A total of 6-30 patients will be accrued for this study.
Primary Purpose: Treatment
Tadashi Mio, MD
United States: Federal Government