A Phase I, Open-Label Study of the Safety, Tolerability and Pharmacokinetics of Lapatinib in Combination With Liposomal Doxorubicin in Patients With Metastatic Breast Cancer
- Evaluate the safety, tolerability, and feasibility of pegylated doxorubicin HCl
liposome (PLD) when administered with lapatinib, particularly in terms of cardiac
safety, in patients with metastatic breast cancer.
- Determine the optimally tolerated regimen (OTR) of PLD when administered with lapatinib
in these patients.
- Determine the pharmacokinetic profiles of lapatinib and PLD when given in combination
at the OTR.
- Describe any preliminary evidence of efficacy of lapatinib and PLD in these patients.
OUTLINE: This is an open-label, dose-escalation study of pegylated doxorubicin HCl liposome
Patients receive oral lapatinib once daily on days 1-28 and PLD IV over at least 30 minutes
on day 1. Treatment repeats every 28 days for up to 8 courses in the absence of disease
progression or unacceptable toxicity. Lapatinib may be continued alone in the absence of
disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of PLD until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients
experience dose-limiting toxicity.
After completing study treatment, patients are followed for 30 days.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Throughout treatment and up to 30 days post-treatment
Mary Cianfrocca, DO
Robert H. Lurie Cancer Center
United States: Food and Drug Administration
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|