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Liposomal Doxorubicin and Trastuzumab in Treating Women With Advanced Breast Cancer

Sponsor
NYU Langone Health (Other)
Overall Status
Completed
CT.gov ID
NCT00006825
Collaborator
National Cancer Institute (NCI) (NIH)
1
Location

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of liposomal doxorubicin and trastuzumab in treating women who have advanced breast cancer.

Condition or Disease Intervention/Treatment Phase
  • Biological: trastuzumab
  • Drug: pegylated liposomal doxorubicin hydrochloride
 Phase 1/Phase 2

Detailed Description

OBJECTIVES:

  • Determine the toxicity, including cardiac toxicity, of doxorubicin HCl liposome and trastuzumab (Herceptin) in women with advanced HER-2/neu-overexpressing breast cancer.

  • Determine the efficacy of this regimen in these patients.

OUTLINE: Patients receive doxorubicin HCl liposome IV over 1 hour on day 1, followed by trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
A Safety Study Of Doxil And Herceptin In Patients With Advanced Her-2 Overexpressing Breast Cancer
Study Start Date :
Jul 1, 2000
Actual Primary Completion Date :
Jul 1, 2004

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:

    • Histologically proven breast cancer

    • Metastatic disease OR

    • Locoregional relapse following optimal adjuvant therapy and regional treatment

    • HER-2/neu overexpression (3+ by immunohistochemistry OR gene amplification by FISH)

    • Hormone receptor status:

    • Not specified

    PATIENT CHARACTERISTICS:
    Age:
    • 18 and over
    Sex:
    • Female
    Menopausal status:
    • Not specified
    Performance status:
    • ECOG 0-2
    Life expectancy:
    • Not specified
    Hematopoietic:

    • Absolute neutrophil count at least 1,500/mm3

    • Platelet count at least 100,000/mm3

    • Hemoglobin at least 10 g/dL

    Hepatic:

    • SGOT and SGPT no greater than 3 times upper limit of normal (ULN)

    • Alkaline phosphatase no greater than 2 times ULN unless documented to be arising from bone

    • Bilirubin no greater than 1.5 times ULN

    Renal:

    • BUN less than 1.5 times ULN

    • Creatinine less than 1.5 times ULN

    Cardiovascular:

    • LVEF normal by radioisotope method

    • No history of congestive cardiac failure, myocardial infarction, cardiac arrhythmia, or ischemic heart disease requiring medication

    Other:

    • Not pregnant or nursing

    • Fertile patients must use effective contraception

    • No known sensitivity to benzyl alcohol

    • No other prior malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix

    PRIOR CONCURRENT THERAPY:
    • See Disease Characteristics
    Biologic therapy:
    • Not specified
    Chemotherapy:
    • No prior doxorubicin greater than 240 mg/m2
    Endocrine therapy:
    • Not specified
    Radiotherapy:
    • Prior radiotherapy to left breast or chest wall allowed
    Surgery:
    • Not specified

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NYU School of Medicine's Kaplan Comprehensive Cancer Center New York New York United States 10016

    Sponsors and Collaborators

    • NYU Langone Health
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Matthew D. Volm, MD, NYU Langone Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00006825
    Other Study ID Numbers:
    • CDR0000068331
    • P30CA016087
    • NYU-0012
    • ALZA-00-001-ii
    • NCI-G00-1878
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Mar 28, 2011
    Last Verified:
    Mar 1, 2011
    Keywords provided by , ,
    stage IV breast cancer
    recurrent breast cancer
    Additional relevant MeSH terms:
    Breast Neoplasms
    Doxorubicin
    Liposomal doxorubicin
    Trastuzumab

    Study Results

    No Results Posted as of Mar 28, 2011