Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	pre-/postmenopausal	NCI	OSU-94HO429 NCI-T94-0155D, T94-0155

Objectives

I.  Evaluate the efficacy of aminocamptothecin (9-AC) in patients with 
refractory breast cancer.

II.  Document the toxicity of 9-AC given with granulocyte colony-stimulating 
factor therapy in this patient population.

III.  Study in vitro topoisomerase I/DNA adduct formation in tumor samples and 
circulating blood and any relationship to antitumor activity and toxicity.

IV.  Correlate steady-state 9-AC levels with topoisomerase I/DNA adduct 
formation.

Entry Criteria

Disease Characteristics:

Histologically confirmed, metastatic or locally recurrent adenocarcinoma of
the breast no longer responsive to therapy
  Failed to respond or progressed on therapy OR
  Relapsed less than 12 months following completion of therapy

Bidimensionally measurable disease required, i.e.:
  Lesion on physical exam or radiograph adequate to evaluate response (e.g.,
     at least 1 cm on CT)
  Measurable lytic bone lesion

The following are not considered measurable:
  Pleural or peritoneal effusions 
  Bone lesions on bone scan only

Previously treated, clinically stable brain metastases eligible
  No untreated or currently irradiated brain metastases

Hormone receptor status:
  Not specified

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  1 prior chemotherapy regimen for recurrent or metastatic disease required
  1 prior chemotherapy regimen as adjuvant therapy allowed
  At least 3 weeks since chemotherapy and recovered

Endocrine therapy:
  1 prior hormonal therapy regimen for metastatic disease and/or as adjuvant
     therapy allowed
  At least 2 weeks since hormonal therapy

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

Surgery:
  At least 3 weeks since surgery and recovered

Patient Characteristics:

Age:
  Not specified

Sex:
  Not specified

Menopausal status:
  Pre- and postmenopausal

Performance status:
  SWOG 0-2

Life expectancy:
  At least 3 months

Hematopoietic:
  AGC greater than 1,500
  Platelets greater than 125,000

Hepatic:
  Bilirubin less than 1.5 mg/dL
  AST and ALT less than 2.5 times normal

Renal:
  Creatinine less than 1.3 mg/dL or within institutional normal limits

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

Blood analysis to determine eligibility completed within 2 weeks prior to
registration and staging studies completed within 3 weeks prior to
registration

Expected Enrollment

A maximum of 29 patients will be accrued; if no more than 1 response is seen 
in the first 10 evaluable patients, the study will close.

Outline

All patients receive aminocamptothecin by continuous infusion for 3 days, 
followed by granulocyte colony-stimulating factor for approximately 1 week.

Patients may be re-treated every 2 weeks in the absence of progressive disease 
or unacceptable toxicity; the aminocamptothecin dose may be increased after 2 
courses.

Kraut EH, Balcerzak SP, Young D, et al.: A phase II study of 9-aminocamptothecin in patients with refractory breast cancer. Cancer Invest 18 (1): 28-31, 2000.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Eric Kraut, MD, Protocol chair		Ph: 614-293-2887