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 ICC-89U3 NCI-T89-0166D, T89-0166

Objectives

I.  Investigate to what extent piroxantrone administered as an intravenous 
infusion over 60 minutes every 3 weeks can produce objective responses in 
patients with advanced renal cancer.
II.  Evaluate further 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:

Patients at least 18 years of age 
with histologically or cytologically confirmed advanced adenocarcinoma of the 
kidney who have received no previous chemotherapy.  Prior treatment with 
biologic (e.g., interferon) and hormonal agents is allowed.  No surgery or 
radiotherapy is allowed within the 28 days preceding entry.  Patients must 
have at least one clearly defined lesion measurable in 2 perpendicular 
diameters; a lesion pictured by ultrasound or CAT scan is acceptable provided 
it meets this condition and the procedure can be repeated serially.  Baseline 
measurements of indicator lesions must be obtained within 14 days prior to 
entry.  Indicator lesions must not have been irradiated previously.  A life 
expectancy of at least 60 days and an ECOG performance status of 2 or better 
are required, as are the following laboratory parameters (measured within 14 
days prior to entry):  hemoglobin at least 10.0 mg/dl (transfusion 
acceptable), WBC at least 4,000, platelets at least 100,000, granulocytes at 
least 2,000, BUN no more than 25.0 mg/dl, creatinine no more than 1.7 mg/dl, 
and bilirubin no more than 2.0 mg/dl.  A left ventricular ejection fraction of 
at least 45% by MUGA scan is required, and there must be no history of 
significant heart disease (congestive heart failure, coronary artery disease, 
or clinically significant arrhythmia).  Patients must be free of any acute or 
uncontrolled infection.  Women who are pregnant are ineligible; fertile women 
must be practicing effective contraception at the time of entry and make a 
firm commitment to continue while on study.

Expected Enrollment

If there is at least one objective response in the first 15 evaluable 
patients, 15 additional patients will be entered.  Accrual of a sufficient 
number of patients to establish a negative result is expected to require 18-24 
months.

Outline

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

Shevrin D, Wade J, Mullane M, et al.: Phase II study of piroxantrone in advanced renal cell cancer (RCC): an Illinois Cancer Center study. [Abstract] Proceedings of the American Society of Clinical Oncology 12: A-749, 240, 1993.

Trial Contact Information

Trial Lead Organizations

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Daniel Shevrin, MD, Protocol chair(Contact information may not be current)		Ph: 312-908-5250