Phase I Study of Irinotecan Followed by Capecitabine in Patients With Advanced Breast Carcinoma
- Determine the maximum tolerated dose of capecitabine and irinotecan in women with
advanced breast cancer.
- Determine the degree of accumulation of cells in S-phase in tumor biopsies from
patients treated with this regimen.
- Determine the dose-limiting toxicity and other major or unusual toxic effects of this
regimen in these patients.
- Determine any antitumor activity of this regimen in these patients.
- Determine the pharmacokinetics of this regimen, including the active metabolite SN-38,
in these patients.
- Correlate pharmacokinetic parameters of this regimen with the biological changes
observed in these patients.
- Determine, preliminarily, the relationship of tumor response with modulation of S-phase
in patients treated with this regimen.
OUTLINE: This is a dose-escalation study.
Patients receive irinotecan IV over 1.5 hours on days 1, 8, 22, and 29 and oral capecitabine
twice daily on days 1-14 and 23-36. Treatment continues in the absence of disease
progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of irinotecan and capecitabine until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 8-37 patients will be accrued for this study within 18-24
Intervention Model: Single Group Assignment, Primary Purpose: Treatment
Tracey O'Connor, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|