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

Alternate Title

Sedoxantrone Trihydrochloride in Treating Patients With Metastatic Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over Pharmaceutical / Industry PD-958-05 NCI-V97-1208

Objectives

I. Determine the antitumor activity of CI-958 in three separate cohorts with 
metastatic breast cancer.

II. Determine the safety of CI-958 administered to patients with metastatic 
breast cancer.

Entry Criteria

Disease Characteristics:

Histologically proven metastatic breast cancer
 -Stage IV
 -Cohort 1: Failure to respond to or relapse from one chemotherapy            

            regimen containing doxorubicin or mitoxantrone
 -Cohort 2: Failure to respond to or relapse from one chemotherapy
            regimen that does not contain doxorubicin or                      

            mitoxantrone
 -Cohort 3: No prior chemotherapy 

Bidimensionally measurable lesions that have not been irradiated

No brain metastases

--Prior /Concurrent Therapy--

Biologic therapy:
 No concurrent immunotherapy

Chemotherapy:
 No prior chemotherapy within 3 weeks of study
 No prior nitrosourea and mitomycin within 6 weeks of study
 No more than 1 prior chemotherapy regimen for metastatic breast cancer
 No concurrent chemotherapy

Endocrine therapy:
 No prior hormonal therapy within 4 weeks of study
 No concurrent hormonal therapy

Radiotherapy:
 No prior radiation therapy within 3 weeks prior to study (not
  including palliative radiotherapy to nonbone marrow sites)
 No concurrent radiotherapy, except for small port palliative radiation

Surgery:
 No major surgery within 14 days prior to study
 No concurrent surgery

Patient Characteristics:

Age:
 18 and over

Sex:
 Female

Performance Status:
 WHO 0-2

Life Expectancy:
 Greater than 9 weeks

Hematopoietic:
 Absolute granulocyte count at least 1,500/mm3
 Platelet count at least 100,000/mm3
 
Hepatic:
 Bilirubin no greater than 1.5 times the upper limit of normal
 SGOT no greater than 1.5 times the upper limit of normal
 Adequate liver function must be obtained within 1 week prior to study

Renal:
 Creatinine no greater than 1.5 times the upper limit of normal

Cardiovascular:
 No active congestive heart failure
 No uncontrolled angina
 No myocardial infarction within 6 months prior to study
 LVEF at least 45% (obtained within 3 weeks prior to study)

Other:
 No concurrent serious infection or illness
 Not pregnant or nursing
 Effective contraceptive method during and up to 3 months following study   
  completion
 No psychosis or mental disability
 Disease free cancer and off all therapy for 3 years, except:
  Nonmelanoma skin cancer
  In situ cervical cancer
      

Expected Enrollment

 30 to 90 evaluable patients will be enrolled. 

Outline

This is a nonrandomized, noncomparative, open label study.

Patients receive a single dose of CI-958 on day 1 of a three week cycle. 
CI-958 is administered in 2 hour intravenous infusions by peripheral vein or 
central line catheter.

Subsequent doses of CI-958 are administered every 21 days, unless the patient 
has an adverse event or has not recovered from the previous course. 

Trial Contact Information

Trial Lead Organizations

Pfizer Incorporated - Ann Arbor

William Grove, MS, Protocol chair		Ph: 313-996-7839