Status:
COMPLETED
Lapatinib and Doxorubicin Hydrochloride Liposome in Treating Patients With Metastatic Breast Cancer
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
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 pat...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00316875
Start Date
May 1 2006
End Date
August 1 2011
Last Update
November 8 2013
Active Locations (1)
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1
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013