Clinical trial NCT00006825: Liposomal Doxorubicin and Trastuzumab in Treating Women With Advanced Breast Cancer
Official title: A Safety Study Of Doxil And Herceptin In Patients With Advanced Her-2 Overexpressing Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Keywords: stage IV breast cancer
recurrent breast cancer
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU School of Medicine's Kaplan Comprehensive Cancer Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Matthew D. Volm, MD
role: STUDY_CHAIR
References: