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Liposomal Doxorubicin and Trastuzumab in Treating Women With Advanced Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006825
First Posted: January 27, 2003
Last Update Posted: March 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
New York University School of Medicine
  Purpose

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 Intervention Phase
Breast Cancer Biological: trastuzumab Drug: pegylated liposomal doxorubicin hydrochloride Phase 1 Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Safety Study Of Doxil And Herceptin In Patients With Advanced Her-2 Overexpressing Breast Cancer

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Study Start Date: July 2000
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006825


Locations
United States, New York
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
National Cancer Institute (NCI)
Investigators
Study Chair: Matthew D. Volm, MD New York University School of Medicine
  More Information

ClinicalTrials.gov Identifier: NCT00006825     History of Changes
Other Study ID Numbers: CDR0000068331
P30CA016087 ( U.S. NIH Grant/Contract )
NYU-0012
ALZA-00-001-ii
NCI-G00-1878
First Submitted: December 6, 2000
First Posted: January 27, 2003
Last Update Posted: March 28, 2011
Last Verified: March 2011

Keywords provided by New York University School of Medicine:
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Doxorubicin
Liposomal doxorubicin
Trastuzumab
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action