Doxorubicin in Treating Women With Advanced Breast Cancer
NCT ID: NCT00003165
Last Updated: 2013-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
25 participants
INTERVENTIONAL
1997-12-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of doxorubicin in treating women with advanced metastatic breast cancer.
Detailed Description
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OUTLINE: This is an open label, multicenter study. Patients receive doxorubicin-HPMA conjugate (PK1) by intravenous infusion once every 3 weeks. Patients may receive a total of 6 courses of treatment in the absence of toxicity and progressive disease.
PROJECTED ACCRUAL: 14-25 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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doxorubicin-HPMA conjugate
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: Hemoglobin at least 10 g/dL Neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 11.7 mg/dL AST/ALT no greater than 2 times upper limit of normal (5 times upper limit of normal in presence of liver metastases) Renal: Creatinine no greater than 1.7 mg/dL Cardiovascular: No concurrent treatment for congestive cardiac failure Cardiac function within normal limits by MUGA or ECHO scan, if prior anthracycline therapy Other: Not pregnant or nursing Fertile patients must use effective contraception No concurrent nonmalignant systemic disease No active uncontrolled infection No prior history of malignant disease except: Squamous cell carcinoma of the skin Curatively treated carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunological therapy Chemotherapy: At least 1 prior chemotherapy regimen for advanced disease (including adjuvant therapy), but not more than 2 prior regimens At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered Cumulative dose of prior epirubicin no greater than 450 mg/m2 Cumulative dose of prior doxorubicin no greater than 240 mg/m2 No concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Low dose steroid therapy allowed if dose established at least 4 weeks prior to study Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: Not specified Other: No concurrent experimental therapy
18 Years
FEMALE
No
Sponsors
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University of Glasgow
OTHER
Principal Investigators
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Chris Twelves, MD, BMedSci, FRCP
Role: STUDY_CHAIR
University of Glasgow
Locations
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Cancer Research Campaign Clinical Trials Unit-Birmingham (CRCTU)
Birmingham, England, United Kingdom
Newcastle General Hospital
Newcastle upon Tyne, England, United Kingdom
Weston Park Hospital
Sheffield, England, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Western General Hospital
Edinburgh, Scotland, United Kingdom
Beatson Oncology Centre
Glasgow, Scotland, United Kingdom
Countries
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Other Identifiers
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CRC-PHASE-II-PH2/038
Identifier Type: -
Identifier Source: secondary_id
EU-97028
Identifier Type: -
Identifier Source: secondary_id
CDR0000065966
Identifier Type: -
Identifier Source: org_study_id