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-8930 SWOG-8930

Objectives

I.  Assess the activity of piroxantrone in the treatment of locally advanced 
or metastatic soft tissue sarcoma.
II.  Evaluate the qualitative and quantitative toxicities of piroxantrone 
administered in this disease.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with a histologic diagnosis 
of unresectable, recurrent, or metastatic sarcoma provided they have 
measurable disease (ascites and effusions are not considered measurable).  All 
histologies are eligible, with the exception of Kaposi's sarcoma, Ewing's 
sarcoma, bony sarcomas, lymphoma, extraskeletal chondrosarcoma, and 
mesotheliomas as well as sarcomas originating in bone.  Patients may have 
received up to one prior chemotherapy regimen and up to one prior biologic 
therapy regimen for metastatic disease; they must have been off previous 
chemotherapy or radiotherapy for at least 3 weeks prior to entry and must have 
recovered from any toxicity of prior therapy.  Prior treatment with Adriamycin 
to a total dose of 250 mg/sqm or greater or mitoxantrone to 50 mg/sqm or 
greater is not allowed; an LVEF of at least 45% by MUGA scan is required in 
patients who have received either drug.  A SWOG performance status of 2 or 
better is required, as is adequate hematologic, hepatic, and renal function:  
pretreatment WBC above 3,500, platelets above 100,000, and granulocytes above 
1,500; total bilirubin less than 1.5 mg/dl and SGOT no more than 2.5 x 
institutional upper limit of normal; and creatinine less than 2.0 mg/dl.  
Patients with myocardial infarction within six months or a history of CHF or 
serious arrhythmias requiring treatment are ineligible.  Aside from adequately 
treated basal cell skin cancer, in situ cervical cancer, and other cancer from 
which the patient has been disease-free for more than 5 years, there must be 
no prior malignancy.  Pregnancy and lactation exclude, and men and women of 
reproductive potential must use effective contraception.
Bloodwork and other body fluid analysis required 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 analysis and imaging studies of nonmeasurable disease or 
uninvolved organs must be completed within 42 days prior to registration.

Expected Enrollment

If at least 1 response is observed in the first 15 patients, an additional 15 
patients will be accrued.  The accrual rate for this study is anticipated to 
be 4-5 patients per month.

Outline

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

Zalupski MM, Benedetti J, Balcerzak SP, et al.: Phase II trial of piroxantrone for advanced or metastatic soft tissue sarcomas. A Southwest Oncology Group study. Invest New Drugs 11 (4): 337-41, 1993.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Mark Zalupski, MD, Protocol chair(Contact information may not be current)		Ph: 313-745-4700; 800-527-6266