Doxorubicin in Treating Women With Advanced Breast Cancer
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: doxorubicin-HPMA conjugate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of PK1 in Women With Advanced Breast Cancer |
| Estimated Enrollment: | 25 |
| Study Start Date: | December 1997 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically or cytologically proven advanced metastatic carcinoma of the breast Bidimensionally measurable disease No brain or leptomeningeal disease
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
Contacts and Locations| United Kingdom | |
| Cancer Research Campaign Clinical Trials Unit-Birmingham (CRCTU) | |
| Birmingham, England, United Kingdom, B15 2TT | |
| Newcastle General Hospital | |
| Newcastle Upon Tyne, England, United Kingdom, NE4 6BE | |
| Weston Park Hospital | |
| Sheffield, England, United Kingdom, S1O 2SJ | |
| Aberdeen Royal Infirmary | |
| Aberdeen, Scotland, United Kingdom, AB25 2ZN | |
| Western General Hospital | |
| Edinburgh, Scotland, United Kingdom, EH4 9NQ | |
| Beatson Oncology Centre | |
| Glasgow, Scotland, United Kingdom, G11 6NT | |
| Study Chair: | Chris Twelves, MD, BMedSci, FRCP | University of Glasgow |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00003165 History of Changes |
| Other Study ID Numbers: | CDR0000065966, CRC-PHASE-II-PH2/038, EU-97028 |
| Study First Received: | November 1, 1999 |
| Last Updated: | April 10, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IV breast cancer recurrent breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Doxorubicin Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013