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Phase I/II Clinical and Pharmacological Study of Liposomal Annamycin in Anthracycline-Resistant Breast Cancer


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

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Trial Information

Phase I/II Clinical and Pharmacological Study of Liposomal Annamycin in Anthracycline-Resistant Breast Cancer


OBJECTIVES: I. Determine the observed anti-tumor activity of annamycin liposomal in patients
with anthracycline-resistant locally advanced or metastatic breast cancer. II. Determine the
qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these
patients. III. Determine the clinical pharmacology of this regimen in these patients. IV.
Determine the rationale for the dose and chosen schedule of this regimen in these patients.

OUTLINE: Patients receive annamycin liposomal IV over 60 minutes on day 1. Treatment
continues every 3 weeks for at least 2 courses in the absence of disease progression or
unacceptable toxicity.

PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 7-30
months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Diagnosis of locally advanced or metastatic breast cancer High
likelihood of anthracycline resistance due to prior anthracycline exposure in the adjuvant
or metastatic setting Prior anthraquinone (e.g., mitoxantrone) insufficient Prior
cumulative anthracycline dose limited to doxorubicin-equivalent 350 mg/m2 by IV bolus or
450 mg/m2 by prolonged (at least 48 hours) infusion Measurable or evaluable disease Brain
metastases treated by prior surgery and/or radiotherapy allowed if neurologic status
stable 2 weeks after discontinuation of dexamethasone Hormone receptor status: Not
specified

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Male or female Menopausal status: Not
specified Performance status: Zubrod 0-2 Life expectancy: At least 12 weeks Hematopoietic:
Absolute granulocyte count greater than 1,500/mm3 Platelet count greater than 100,000/mm3
Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL
Cardiovascular: No history of heart failure Ejection fraction at least 55% by
2-dimensional echocardiogram Other: Not pregnant or nursing Negative pregnancy test
Fertile patients must use effective contraception Other prior malignancy allowed if
curatively treated and there is clear diagnosis of metastatic breast cancer requiring
treatment

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent prophylactic filgrastim (G-CSF)
Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy (6
weeks for mitomycin or nitrosourea) and recovered Endocrine therapy: See Disease
Characteristics Radiotherapy: See Disease Characteristics At least 3 weeks since prior
radiotherapy and recovered Surgery: See Disease Characteristics

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:

CDR0000068486

NCT ID:

NCT00012129

Start Date:

September 1998

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • stage IIIA breast cancer
  • recurrent breast cancer
  • stage IIIB breast cancer
  • male breast cancer
  • Breast Neoplasms

Name

Location

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