Chemotherapy in Treating Patients With Breast Cancer

NCT00012129 | Completed Phase 1

• 3 other identifiers: CDR0000068486NYU-9851NCI-G01-1914
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; stage IIIA breast cancer; recurrent breast cancer; stage IIIB breast cancer; male breast cancer

Interventions

liposomal annamycin DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NYU Langone Health: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Matthew D. Volm, MD

  NYU Langone Health

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2001
• First Posted: April 20, 2004
• Study Start: September 1, 1998
• Primary Completion: May 1, 2001
• Last Updated: March 11, 2016

Record last verified: 2016-03

Locations

US (1)