Lung Cancer Clinical Trial
Official title:
Phase I Study of Weekly Irinotecan Combined With Amrubicin in Previously Treated Small-Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as amrubicin and irinotecan, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of amrubicin when
given together with irinotecan in treating patients with recurrent or relapsed extensive
stage small cell lung cancer.
OBJECTIVES:
Primary
- 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.
Secondary
- 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
regimen.
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
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