Spots Global Cancer Trial Database for Lapatinib and Doxorubicin Hydrochloride Liposome in Treating Patients With Metastatic Breast Cancer

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Trial Identification

Brief Title: Lapatinib and Doxorubicin Hydrochloride Liposome in Treating Patients With Metastatic Breast Cancer

Official Title: 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

Study ID: NCT00316875

Conditions

Breast Cancer

Interventions

lapatinib ditosylate

Doxil

Study Description

Brief Summary: RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lapatinib together with doxorubicin hydrochloride liposome may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of doxorubicin hydrochloride liposome when given together with lapatinib in treating patients with metastatic breast cancer.

Detailed Description: OBJECTIVES: Primary * 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. Secondary * 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 (PLD). 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.