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A Safety Study Of Doxil And Herceptin In Patients With Advanced Her-2 Overexpressing Breast Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

A Safety Study Of Doxil And Herceptin In Patients With Advanced Her-2 Overexpressing 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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Matthew D. Volm, MD

Investigator Role:

Study Chair

Investigator Affiliation:

New York University School of Medicine

Authority:

United States: Federal Government

Study ID:

CDR0000068331

NCT ID:

NCT00006825

Start Date:

July 2000

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms

Name

Location

NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016