- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00012129
Chemotherapy in Treating Patients With Breast Cancer
Phase I/II Clinical and Pharmacological Study of Liposomal Annamycin in Anthracycline-Resistant Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I/II trial to study the effectiveness of annamycin liposomal in treating patients who have locally advanced or metastatic breast cancer that has not responded to previous chemotherapy.
Study Overview
Detailed Description
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.
Study Type
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10016
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Matthew D. Volm, MD, NYU Langone Health
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000068486
- NYU-9851
- NCI-G01-1914
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
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University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
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Sidney Kimmel Cancer Center at Thomas Jefferson...Susan G. Komen Breast Cancer FoundationCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
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