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

NCT00316875 | Completed Phase 1 DMC

• 5 other identifiers: NU 05B5P30CA060553NU-05B5NU-1838-001NCI-2011-00325
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer; male breast cancer

Outcome Measures

Primary Outcomes (2)

• Cardiac safety

  Throughout treatment and up to 30 days post-treatment

• Maximum tolerated dose

  After the first cycle of therapy

Secondary Outcomes (2)

• Pharmacokinetic profiles

  After treatment completion for 12 patients treated at the maximum tolerated dose

• Efficacy

  At time of disease progression

Study Arms (1)

Lapatinib Ditosylate and Doxil

EXPERIMENTAL

Drug: lapatinib ditosylate; Drug: Doxil

Interventions

lapatinib ditosylate DRUG

1500 mg orally daily for as long as patients remain on trial (up to 8 cycles).

Lapatinib Ditosylate and Doxil

Doxil DRUG

Administered intravenously (IV) every 4 weeks in a dose-escalating fashion according to a set schedule

Also known as: Doxorubicin HCL Liposome Injection, Dox-SL

Lapatinib Ditosylate and Doxil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Interventions

Lapatinib; liposomal doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• William J Gradishar, M.D.

  Robert H. Lurie Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 19, 2006
• First Posted: April 21, 2006
• Study Start: May 1, 2006
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: November 8, 2013

Record last verified: 2013-11

Locations

US (1)