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 18 and over NCI SWOG-8936 SWOG-8936

Objectives

I.  Assess the response rate and response duration of patients with gastric 
carcinoma treated with piroxantrone.
II.  Evaluate the qualitative and quantitative toxicities of piroxantrone 
administered to patients with gastric carcinoma 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 histologically proven adenocarcinoma of the stomach with gross 
unresectable residual disease that is locally advanced or metastatic, provided 
there is bidimensionally measurable disease.  Patients must not have received 
prior chemotherapy, hormonal therapy, or biologic response modifier therapy, 
and they must not receive concomitant therapy while on protocol.  At least one 
month must have elapsed since prior radiotherapy or surgery, and patients must 
have recovered from all therapy-related toxicities.  A SWOG performance status 
of 2 or better is required, as are the following values for organ function 
parameters:  granulocytes at least 1,500, platelets at least 100,000, serum 
creatinine and serum bilirubin each no greater than 1.5 mg/dl, and SGOT no 
more than 2.5 x institutional normal (no more than 5 x normal if there are 
hepatic metastases).  Patients must not be receiving treatment for cardiac 
disease (arrhythmias, CHF, or coronary artery disease) and must not have had a 
myocardial infarction within the past year; the LVEF as measured by MUGA scan 
must be at least 45%.  Aside from adequately treated basal or squamous cell 
skin cancers, in situ cervical cancer, and other cancer from which the patient 
has been disease-free for 5 years, there must be no prior malignancy.  
Pregnancy and lactation exclude, and patients of reproductive potential must 
practice 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 3-5 responses are observed in the first 20 patients, an additional 15 
patients will be entered.  Accrual is expected to be completed in 6 months.

Outline

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

Hantel A, Tangen C, Gluck WL, et al.: Phase II trial of piroxantrone in gastric carcinoma. A Southwest Oncology Group study. Invest New Drugs 12 (2): 159-61, 1994.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Alexander Hantel, MD, Protocol chair		Ph: 630-527-3788 Email: ahantel@edward.org