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

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Doxorubicin; Lapatinib; Liposomal doxorubicin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the breast with evidence of metastatic disease

• Epidermal growth factor receptor (EGFR) and/or erbB2 positivity not required

• Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension as ≥ 20 mm by conventional techniques OR as ≥ 10 mm by spiral CT scan

• No known brain metastases or leptomeningeal disease

• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Male or female patients

• Menopausal status not specified

• Life expectancy ≥ 12 weeks

• ECOG performance status 0-1

• WBC ≥ 3,000/mm^3

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Bilirubin normal

• AST/ALT ≤ 2.5 times upper limit of normal

• Creatinine normal OR creatinine clearance ≥ 60 mL/min

• LVEF ≥ 50%

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Able to swallow and retain oral medication

• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib

• No gastrointestinal (GI) tract disease resulting in inability to take oral medication

• No malabsorption syndrome or requirement for IV alimentation

• No uncontrolled inflammatory GI disease (e.g., Crohn's disease, ulcerative colitis)

PRIOR CONCURRENT THERAPY:

• Prior trastuzumab (Herceptin ®) allowed

• Prior anthracyclines allowed provided total dose of doxorubicin hydrochloride ≤ 240 mg/m² or epirubicin ≤ 600 mg/m²

• More than 4 weeks since prior major surgery, hormonal therapy (other than replacement therapy), chemotherapy (6 weeks for nitrosoureas or mitomycin C), or radiotherapy and recovered

• No prior surgical procedures affecting absorption

• No prior EGFR-targeting therapies

• At least 7 days since prior and no concurrent CYP3A4 inhibitors

• At least 7 days since prior and no concurrent gastric pH modifiers

• Antacids allowed within 1 hour before and after lapatinib dosing

• At least 14 days since prior and no concurrent CYP3A4 inducers, including dexamethasone or dexamethasone equivalent dose > 1.5 mg/day

• At least 6 months since prior and no concurrent amiodarone

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No concurrent prophylactic growth factor support

• No concurrent herbal medications

• No other concurrent investigational agents or anticancer therapy