Liposomal Doxorubicin and Trastuzumab in Treating Women With Advanced Breast Cancer

NCT ID: NCT00006825

Last Updated: 2011-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-07-31

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.

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.

Conditions

Breast Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

trastuzumab

Intervention Type: BIOLOGICAL

pegylated liposomal doxorubicin hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Principal Investigators

Matthew D. Volm, MD

Role: STUDY_CHAIR

NYU Langone Health

Locations

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

P30CA016087

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NYU-0012

Identifier Type: -

Identifier Source: secondary_id

ALZA-00-001-ii

Identifier Type: -

Identifier Source: secondary_id

NCI-G00-1878

Identifier Type: -

Identifier Source: secondary_id

CDR0000068331

Identifier Type: -

Identifier Source: org_study_id