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 Closed 18 and over NCI SWOG-8933 SWOG-8933

Objectives

I.  Assess the clinical response rate of piroxantrone in patients with 
pancreatic adenocarcinoma.
II.  Evaluate the qualitative and quantitative toxicities of piroxantrone in 
this patient population in a Phase II study.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients at least 18 years of age 
with pathologically verified adenocarcinoma of the exocrine pancreas that is 
advanced, recurrent, or progressive and not amenable to surgery or 
radiotherapy, provided they have bidimensionally measurable disease (defined 
below).  Patients must not have received prior chemotherapy, hormonal therapy, 
or biologic response modifier therapy; at least one month must have elapsed 
since prior radiotherapy, and patients must be recovered from all 
therapy-associated toxicities.  At least 2 weeks must have elapsed since 
surgery, and patients must have recovered from postoperative complications.  
Concomitant therapy is not allowed.  A SWOG performance status of 2 or better 
is required, and adequate hematopoietic, hepatic, and renal function must be 
documented as follows:  granulocytes at least 1,500 and platelets at least 
100,000; serum 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); and serum creatinine no greater than 1.5 mg/dl.  
Patients must not have had a myocardial infarction within the past year, and 
the LVEF as measured by MUGA scan must be at least 45%; patients must not be 
receiving treatment for cardiac disease (arrhythmias, CHF, or coronary artery 
disease).  Aside from adequately treated basal cell or squamous cell skin 
cancers, any in situ cancer, or other cancer from which the patient has been 
disease-free for five years, there must be no prior malignancy.  Pregnancy and 
lactation exclude, and men and women of reproductive potential must practice 
effective contraception.
Measurable disease is defined as either 1) a lesion (other than a bone lesion) 
with clearly defined margins (by photograph, x-ray, or scan) with 2 measurable 
diameters, one of which is greater than 0.5 cm or 2) a palpable lesion with 
both diameters 2 cm or greater.
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

20 patients will be entered over a period of about 7 months.  If 3 to 5 
responses are observed, an additional 15 patients will be accrued.

Outline

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

Jenkins TR, Tangen C, Macdonald JS, et al.: A phase II trial of piroxantrone in adenocarcinoma of the pancreas. A Southwest Oncology Group study. Invest New Drugs 11 (4): 329-31, 1993.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Terry Jenkins, MD, Protocol chair		Ph: 979-776-2000 Email: drtrj@yahoo.com