Know Cancer

forgot password

A Phase II Trial of PK1 in Women With Advanced Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

A Phase II Trial of PK1 in Women With Advanced Breast Cancer

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.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically proven advanced metastatic
carcinoma of the breast Bidimensionally measurable disease No brain or leptomeningeal

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Chris Twelves, MD, BMedSci, FRCP

Investigator Role:

Study Chair

Investigator Affiliation:

University of Glasgow


United States: Federal Government

Study ID:




Start Date:

December 1997

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms