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

Alternate Title

Aminocamptothecin in Treating Women With Advanced Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	over 18	NCI	CWRU-ICC-3194 NCI-T94-0153D, T94-0153

Objectives

I.  Assess the response rate and duration of response to aminocamptothecin 
(9-AC) administered as a 72-hour continuous infusion every 14 days in patients 
with metastatic breast cancer that is progressive after 1 prior chemotherapy 
regimen.

II.  Describe the toxic effects associated with this regimen.

III.  Evaluate 9-AC pharmacokinetic parameters.

Entry Criteria

Disease Characteristics:

Histologically confirmed metastatic breast cancer that has progressed, as
follows:
  Previously treated with adjuvant chemotherapy and 1 chemotherapy regimen for
  metastatic disease

  Relapsed within 6 months of adjuvant therapy without subsequent chemotherapy
  regimen for metastatic disease

Hormone receptor status:
  Hormone receptor-positive bone or soft-tissue only disease must have
  progressed after 1 prior chemotherapy and 1 prior hormonal regimen

Disease bidimensionally measurable, i.e.:
  By ruler or caliper
  With clearly defined borders on CT or x-ray (including previously
     unirradiated lytic lesion)
  By palpation with sharply defined borders (lymph nodes or subcutaneous mass)
  Previously irradiated lesion with clear progression

The following are not considered measurable:
  Elevated CEA
  Hepatomegaly
  Ascites
  Pleural effusions
  Positive nuclear scan
  Bone scan
  Poorly defined pelvic or abdominal mass

No CNS metastases

No ascites detectable on physical exam

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  See Disease Characteristics
  No prior high-dose chemotherapy with stem cell support
  At least 4 weeks since chemotherapy (6 weeks since mitomycin or
     nitrosoureas) and recovered

Endocrine therapy:
  See Disease Characteristics

Radiotherapy:
  No prior radiotherapy to 25% or more of the bone marrow
  At least 3 weeks since radiotherapy and recovered

Surgery:
  More than 3 weeks since major surgery

Patient Characteristics:

Age:
  Over 18

Sex:
  Not specified

Menopausal status:
  Pre- or postmenopausal

Performance status:
  ECOG 0-2

Life expectancy:
  Greater than 12 weeks

Hematopoietic:
  WBC at least 4,000
  AGC at least 1,500
  Platelets at least 100,000

Hepatic:
  Bilirubin no greater than 1.5 mg/dL
  AST less than 3 times normal
  Alkaline phosphatase less than 3 times normal (unless further elevation is
     due to bone metastases and liver disease is excluded)
  PT normal

Renal:
  Creatinine no greater than 1.5 mg/dL OR
  Creatinine clearance at least 60 mL/min
  Electrolytes (including calcium) normal

Other:
  No active infection
  No second malignancy within 5 years except curatively treated:
     Nonmelanomatous skin cancer
     Carcinoma in situ of the cervix
  No pregnant or nursing women
  Effective contraception required of fertile women

Blood/body fluid analyses to determine eligibility and imaging studies and
physical exams for tumor measurement completed within 14 days prior to
registration

Expected Enrollment

A maximum of 30 patients will be accrued over 10-18 months; if no more than 1 
response is seen in the first 15 evaluable patients, the study will close.

Outline

All patients receive aminocamptothecin by continuous infusion over 3 days.  
Courses repeat every 14 days in stable and responding patients.  The dose may 
be increased if there is no unacceptable toxicity after 3 courses.

Patients are followed every 3 months.

Trial Contact Information

Trial Lead Organizations

Ireland Cancer Center at University Hospitals/Case Medical Center

Gary Schnur, MD, Protocol chair(Contact information may not be current)		Ph: 216-844-5432; 800-641-2422