Liposomal Daunorubicin in Treating Patients With Metastatic Breast Cancer

Back to results

Primary Purpose

Status

Unknown status

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

liposomal daunorubicin citrate

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage IV breast cancer, recurrent breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically proven metastatic breast cancer Measurable disease No bone metastases only No CNS involvement or leptomeningeal disease Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) AST or ALT less than 2 times ULN (less than 5 times ULN if liver metastases present) Renal: Creatinine normal Cardiovascular: Left ventricular ejection fraction at least 50% or normal by echocardiogram or MUGA scan No active ischemic heart disease No uncontrolled hypertension No poorly controlled atrial arrhythmias, symptomatic angina pectoris, or myocardial infarction within the past 6 months No symptomatic congestive heart failure, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft surgery within the past 12 months Other: No other primary cancer within the past 5 years except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No condition that would preclude informed consent or compliance PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior immunotherapy No prior bone marrow transplantation Chemotherapy: Prior nonanthracycline based chemotherapy for breast cancer allowed No prior anthracycline based chemotherapy for metastatic disease Prior anthracycline based adjuvant chemotherapy allowed if: At least 6 months have elapsed from completion of adjuvant therapy until the detection of metastatic disease Cumulative dose no greater than 300 mg/m2 Endocrine therapy: At least 3 weeks since prior hormonal therapy No concurrent hormonal or corticosteroid therapy for breast cancer Radiotherapy: At least 2 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: Not specified

Sites / Locations

Leicester Royal Infirmary NHS Trust

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004207

First Posted

January 21, 2000

Last Updated

June 23, 2014

Sponsor

University of Leicester

1. Study Identification

Unique Protocol Identification Number

NCT00004207

Brief Title

Liposomal Daunorubicin in Treating Patients With Metastatic Breast Cancer

Official Title

A Phase I Study to Determine the Maximum Tolerated Dose of Daunoxome as Therapy for the Treatment of Metastatic Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

July 2000

Overall Recruitment Status

Unknown status

Study Start Date

December 1997 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Leicester

4. Oversight

5. Study Description

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 trial to study the effectiveness of liposomal daunorubicin in treating patients who have metastatic breast cancer.

Detailed Description

OBJECTIVES: I. Determine the maximum tolerated dose of daunorubicin liposomal in patients with metastatic breast cancer. II. Assess the antineoplastic activity and safety profile of this regimen in these patients. OUTLINE: This is a dose escalation study. Patients receive daunorubicin liposomal IV over a minimum of 2 hours on day 1. Treatment repeats every 3 weeks for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of daunorubicin liposomal until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity. Patients with stable or responding disease are followed at 1 and 3 months, then every 3 months for 1 year. PROJECTED ACCRUAL: Approximately 15-20 patients will be accrued for this study within 1 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

stage IV breast cancer, recurrent breast cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

liposomal daunorubicin citrate

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically proven metastatic breast cancer Measurable disease No bone metastases only No CNS involvement or leptomeningeal disease Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) AST or ALT less than 2 times ULN (less than 5 times ULN if liver metastases present) Renal: Creatinine normal Cardiovascular: Left ventricular ejection fraction at least 50% or normal by echocardiogram or MUGA scan No active ischemic heart disease No uncontrolled hypertension No poorly controlled atrial arrhythmias, symptomatic angina pectoris, or myocardial infarction within the past 6 months No symptomatic congestive heart failure, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft surgery within the past 12 months Other: No other primary cancer within the past 5 years except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No condition that would preclude informed consent or compliance PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior immunotherapy No prior bone marrow transplantation Chemotherapy: Prior nonanthracycline based chemotherapy for breast cancer allowed No prior anthracycline based chemotherapy for metastatic disease Prior anthracycline based adjuvant chemotherapy allowed if: At least 6 months have elapsed from completion of adjuvant therapy until the detection of metastatic disease Cumulative dose no greater than 300 mg/m2 Endocrine therapy: At least 3 weeks since prior hormonal therapy No concurrent hormonal or corticosteroid therapy for breast cancer Radiotherapy: At least 2 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: Not specified

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kenneth O'Byrne, MD

Organizational Affiliation

University Hospitals, Leicester

Official's Role

Study Chair

Facility Information:

Facility Name

Leicester Royal Infirmary NHS Trust

City

Leicester

State/Province

England

ZIP/Postal Code

LE1 5WW

Country

United Kingdom

Breast Cancer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial