Liposomal Doxorubicin and Trastuzumab in Treating Women With Advanced Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00006825
First received: December 6, 2000
Last updated: March 25, 2011
Last verified: March 2011

December 6, 2000
March 25, 2011
July 2000
July 2004   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00006825 on ClinicalTrials.gov Archive Site
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Liposomal Doxorubicin and Trastuzumab in Treating Women With Advanced Breast Cancer
A Safety Study Of Doxil And Herceptin In Patients With Advanced Her-2 Overexpressing Breast Cancer

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.

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.

Interventional
Phase 1
Phase 2
Primary Purpose: Treatment
Breast Cancer
  • Biological: trastuzumab
  • Drug: pegylated liposomal doxorubicin hydrochloride
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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July 2004   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006825
CDR0000068331, P30CA016087, NYU-0012, ALZA-00-001-ii, NCI-G00-1878
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New York University School of Medicine
National Cancer Institute (NCI)
Study Chair: Matthew D. Volm, MD New York University School of Medicine
New York University School of Medicine
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP