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Status:

COMPLETED

Abraxane and Lapatinib in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer

Lead Sponsor:

Northwestern University

Collaborating Sponsors:

GlaxoSmithKline

Celgene Corporation

Conditions:

Breast Cancer

Eligibility:

All Genders

18+ years

Phase:

EARLY_PHASE1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as Abraxane, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib may stop the...

Detailed Description

OBJECTIVES: Primary * Determine the clinical response rate, as measured by clinical exam and imaging studies, in patients with stage I-III breast cancer treated with neoadjuvant Abraxane in combinat...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed breast cancer
  • Clinical stage I-III disease
  • Measurable disease defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm with spiral CT scan
  • HER2/neu 3+ by immunohistochemistry or positive by fluorescent in situ hybridization
  • No known brain metastases
  • Hormone receptor status unspecified
  • PATIENT CHARACTERISTICS:
  • Menopausal status not specified
  • Male or female
  • Life expectancy \> 12 weeks
  • ECOG performance status (PS) 0-1 OR Karnofsky PS 80-100%
  • WBC ≥ 3,000/mm\^3
  • Absolute neutrophil count ≥ 1,500 mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Total bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal
  • Creatinine normal OR creatinine clearance ≥ 60 mL/min
  • LVEF ≥ 50% as measured by echocardiogram or MUGA scan
  • No other malignancy within the past year
  • 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 ongoing or active infection
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled illness
  • No gastrointestinal (GI) tract disease that would preclude ability to take oral medication
  • No malabsorption syndrome
  • No requirement for IV alimentation
  • No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
  • PRIOR CONCURRENT THERAPY:
  • No prior chemotherapy, immunotherapy, radiotherapy, or hormonal therapy for breast cancer
  • No prior treatment with epidermal growth factor receptor targeting therapies
  • No prior surgical procedures affecting absorption
  • No prior surgery for breast cancer
  • At least 14 days since prior and no concurrent CYP3A4 inducers, including any of the following:
  • Dexamethasone or dexamethasone equivalent dose ≥ 1.5 mg/day, including any of the following:
  • Cortisone (≥ 50 mg/day)
  • Hydrocortisone (≥ 40 mg/day)
  • Prednisone (≥ 10 mg/day)
  • Methylprednisolone (≥ 8 mg/day)
  • Phenytoin
  • Carbamazepine
  • Phenobarbital
  • Efavirenz
  • Nevirapine
  • Rifampin
  • Rifabutin
  • Rifapentine
  • Hypericum perforatum (St. John's wort)
  • Modafinil
  • At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:
  • Clarithromycin
  • Erythromycin
  • Troleandomycin
  • Delavirdine
  • Ritonavir
  • Indinavir
  • Saquinavir
  • Nelfinavir
  • Amprenavir
  • Lopinavir
  • Itraconazole
  • Ketoconazole
  • Voriconazole
  • Fluconazole (doses up to 150 mg/day are permitted)
  • Nefazodone
  • Fluvoxamine
  • Verapamil
  • Diltiazem
  • Cimetidine
  • Aprepitant
  • Grapefruit or its juice
  • At least 6 months since prior and no concurrent amiodarone
  • At least 2 days since prior and no concurrent gastric pH modifiers\*, including any of the following:
  • Cimetidine
  • Ranitidine
  • Nizatidine
  • Famotidine
  • Omeprazole
  • Esomeprazole
  • Rabeprazole
  • Pantoprazole
  • Lansoprazole
  • NOTE: \*Antacids are allowed within 1 hour before and after administration of study drug
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy, including chemotherapy, radiotherapy, immunotherapy, or antitumor hormonal therapy
  • No concurrent herbal (alternative) medicines
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • Concurrent bisphosphonates allowed

Exclusion

    Key Trial Info

    Start Date :

    May 4 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 5 2010

    Estimated Enrollment :

    30 Patients enrolled

    Trial Details

    Trial ID

    NCT00331630

    Start Date

    May 4 2006

    End Date

    August 5 2010

    Last Update

    March 6 2020

    Active Locations (5)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (5 locations)

    1

    Northwestern University, Northwestern Medical Faculty Foundation

    Chicago, Illinois, United States, 60611-3013

    2

    Hematology-Oncology Associates of Illinois

    Chicago, Illinois, United States, 60611

    3

    Midwest Center for Hematology/Oncology

    Joliet, Illinois, United States, 60432

    4

    Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields

    Olympia Fields, Illinois, United States, 60461