Spots Global Cancer Trial Database for Doxorubicin in Treating Women With Advanced Breast Cancer
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Trial Identification
Brief Title: Doxorubicin in Treating Women With Advanced Breast Cancer
Official Title: A Phase II Trial of PK1 in Women With Advanced Breast Cancer
Study ID: NCT00003165
Conditions
Interventions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different forms may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of doxorubicin in treating women with advanced metastatic breast cancer.
Detailed Description: OBJECTIVES: I. Determine the antitumor activity of doxorubicin-HPMA conjugate (PK1) in women with advanced breast cancer. 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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
Contact Details
Name: Chris Twelves, MD, BMedSci, FRCP
Affiliation: University of Glasgow
Role: STUDY_CHAIR
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