Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Alternate Title

Aminocamptothecin in Treating Women With Metastatic Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	DFCI-95028 NCI-T94-0156D, T94-0156

Objectives

I.  Assess the clinical response to aminocamptothecin administered as a 
72-hour infusion every 14 days with granulocyte colony-stimulating factor in 
women with metastatic breast cancer who have not received prior chemotherapy 
for metastatic disease.

II.  Assess the toxicity of this treatment.

III.  Obtain laboratory data on changes in topoisomerase I/II levels as a 
result of this treatment.

Entry Criteria

Disease Characteristics:

Confirmed metastatic breast cancer
  Any CNS metastases treated and stable for 8 weeks
  No lymphangitic spread
  No liver or marrow metastases causing significant dysfunction

Measurable disease
  Measurable in 2 perpendicular diameters OR
  Hepatic defect greater than 1.5 cm on CT

Hormone receptor status:
  Not specified

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  No prior treatment for metastatic or recurrent disease
  At least 4 weeks since adjuvant chemotherapy and recovered
  More than 6 weeks since nitrosoureas or mitomycin

Endocrine therapy:
  Prior endocrine therapy unlimited 

Radiotherapy:
  At least 4 weeks since radiotherapy and recovered

Surgery:
  Not specified

Patient Characteristics:

Age:
  At least 18

Sex: 
  Women only

Menopausal status:
  Not restricted

Performance status:
  ECOG 0-2

Life expectancy:
  At least 8 weeks

Hematopoietic:
  WBC at least 3,000 
  ANC at least 1,500 if WBC 4,000 or less
  Platelets at least 100,000
  Hemoglobin at least 10 g/dL

Hepatic:
  Bilirubin no greater than 1.5 mg/dL
  AST no greater than 3 times normal
  Alkaline phosphatase less than 3 times normal

Renal:
  Creatinine no greater than 1.5 mg/dL

Other:
  No severe malnutrition
  No intractable emesis
  No active infection
  No significant medical condition that would preclude participation
  No second malignancy within 5 years except adequately treated:
     Nonmelanomatous skin cancer
     Cervical carcinoma in situ
  No pregnant or nursing women
  Adequate contraception required

Imaging/exams for tumor measurement within 14 days prior to registration
Blood/body fluid analyses within 7 days prior to registration

Expected Enrollment

30 patients will be accrued for this multicenter study.  If fewer than 2 of 
the first 15 patients respond, the study will be closed.

Outline

All patients receive aminocamptothecin by 72-hour continuous infusion every 14 
days for a minimum of 2 courses.  Patients with stable disease receive a 
maximum of 6 courses.  Granulocyte colony-stimulating factor is given from day 
5 until the postnadir white blood cell count reaches 10,000.

Concurrent treatment with radiotherapy, cytotoxic chemotherapy, and other 
investigational agents is not permitted.

Trial Contact Information

Trial Lead Organizations

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Charles Shapiro, MD, Protocol chair		Ph: 614-293-6401 Email: charles.shapiro@osumc.edu