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 no age specified NCI SWOG-8911 SWOG-8911

Objectives

I.  Evaluate the response rate to piroxantrone in patients with refractory 
carcinoma of the breast.
II.  Evaluate the toxicities of piroxantrone in this patient population.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Female patients with histologically 
proven refractory carcinoma of the breast that is recurrent or progressive and 
not amenable to curative surgery or radiotherapy, provided they are ineligible 
for higher priority SWOG protocols.  Known brain metastasis exclude, as do 
pleural effusions, pericardial effusions, and ascites if they are the sole 
evidence of disease.  Patients may be ER+, ER-, or ER unknown; ER+ patients 
must have failed a trial of endocrine therapy, and they may have received any 
number of prior hormonal regimens provided at least 2 weeks have elapsed since 
such therapy.  Patients may have received one and only one chemotherapy 
regimen for metastatic or recurrent breast cancer and may have also received 
adjuvant chemotherapy.  Prior immunotherapy is not allowed.  At least 4 weeks 
must have elapsed since prior chemotherapy or radiotherapy (6 weeks for 
mitomycin or nitrosoureas).  Patients must have bidimensionally measurable 
disease  with clearly defined margins on x-ray or CT scan, or photographable 
skin lesions with at least one dimension greater than 0.5 cm (bone lesions 
excluded), or palpable lesions with both diameters at least 2 cm; those with 
nonfocal liver metastases, lytic or blastic bone lesions, nonmeasurable masses 
on CT scan, adrenal masses on CT scan, or elevated tumor markers as the only 
evidence of disease are excluded.  A SWOG performance status of 0-2 is 
required, as are adequate parameters of organ function:  WBC at least 4,000 
and platelets at least 100,000; serum creatinine no greater than 2.0 mg/dl and 
calculated or measured creatinine clearance at least 60 ml/minute; total 
bilirubin no greater than 1.5 mg/dl and SGOT no greater than 2.5 x 
institutional normal (no greater than 5 x institutional normal if liver is 
involved with tumor).  Patients previously treated with doxorubicin or 
mitoxantrone to a cumulative dose of 250 mg/sqm or more or 50 mg/sqm or more, 
respectively, must have an LVEF as measured by MUGA scan of at least 45%.  
Patients with an MI within the past 6 months, CHF, or serious arrhythmias that 
require medical treatment are ineligible.  Patients must have had no prior 
second malignancy except for adequately treated basal cell or squamous cell 
skin cancer, in situ cervical cancer, and other cancer from which the patient 
has been disease free for at least 5 years.  Women who are pregnant or 
lactating are ineligible, and women of childbearing potential must practice 
adequate contraception.  Bloodwork and other body fluid analyses for 
eligibility determination and imaging studies and physical examination for 
tumor measurement must be completed within 14 days prior to registration; 
screening exams other than blood/body fluid analyses and imaging studies of 
nonmeasurable disease or uninvolved organs must be completed within 42 days 
prior to registration.  While on study patients must not receive concomitant 
chemotherapy, immunotherapy, or radiotherapy.

Expected Enrollment

If at least 2 responses are observed in the first 25 patients, an additional 
25 patients will be entered.  The anticipated accrual rate is 35 
patients/year, with approximately 40% having had prior doxorubicin exposure.

Outline

Nonrandomized Study.
Single-agent Chemotherapy.  Piroxantrone, NSC-349174.

Ravdin PM, Green S, Doroshow JH, et al.: Phase II trial of piroxantrone in metastatic breast cancer. A Southwest Oncology Group study. Invest New Drugs 12 (4): 333-6, 1994.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Peter Ravdin, MD, Protocol chair		Ph: 210-567-4777 Email: pmravdin@aol.com