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-8945 SWOG-8945

Objectives

I.  Evaluate the response rate of piroxantrone in patients with Stage III or 
IV renal cell carcinoma.
II.  Assess the qualitative and quantitative toxicities of piroxantrone 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 Stage III or IV renal cell carcinoma who are not 
eligible for higher priority Southwest Oncology Group studies; CNS involvement 
excludes.  Bidimensionally measurable disease (defined below) is required.  
Patients may have received one prior biological response modifier therapy or 
one prior hormonal therapy such as depo-provera; those who received coumarin 
or cimetidine as their only prior therapy are also eligible.  Prior surgery 
and/or radiotherapy to less than 25% of the bone marrow is allowed, but 
measurable disease must exist outside of the previously irradiated port.  For 
patients with prior surgery, radiotherapy, or biologic therapy (including IL-2 
and LAK cells), the nadirs of leukopenia and thrombocytopenia must be passed 
and evidence of hematologic recovery must be demonstrated.  No prior cytotoxic 
chemotherapy is allowed, and concomitant radiotherapy to areas other than 
whole brain, chemotherapy, hormonal therapy, and immunotherapy must not be 
planned.  A SWOG performance status of 2 or better is required, as is 
documentation of adequate physiologic function:  WBC at least 4,000, platelets 
at least 100,000 and AGC at least 1,500; serum bilirubin no greater than 2.0 
mg/dl; and serum creatinine no greater than 1.5 mg/dl and/or 24-hour or 
calculated creatinine clearance at least 50 ml/min.  Patients must have normal 
cardiac function as documented by MUGA scan.  Patients with a myocardial 
infarction within six months or a history of CHF or arrhythmias requiring 
treatment are not eligible.  No prior malignancy is allowed except for 
adequately treated basal or squamous cell skin cancer, in situ cervical 
cancer, and other cancer from which the patient has been disease-free for 5 
years.  Pregnancy and lactation exclude, and patients of reproductive 
potential must practice effective contraception.
Measurable disease is defined as either 1) a bidimensionally measurable lesion 
with clearly defined margins by medical photograph (skin lesions), x-ray, or 
scan and at least one diameter greater than 0.5 cm (bone lesions are not 
included), or 2) a palpable lesion with both diameters 2 cm or greater.  
Cytologically positive pleural effusions, ascites, and disease documented by 
indirect evidence only (e.g., lab values) do not constitute measurable disease.
Bloodwork for determining eligibility and imaging studies and physical 
examination for tumor measurement must be completed within 14 days prior to 
registration.

Expected Enrollment

Initially, 20 patients will be evaluated for response; if any responses are 
observed, an additional 20 patients will be entered.  The accrual rate is 
anticipated to be 7 patients per month.

Outline

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

Allen A, Wolf M, Crawford ED, et al.: Phase II evaluation of piroxantrone in renal cell carcinoma. A Southwest Oncology Group Study. Invest New Drugs 10 (2): 129-32, 1992.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Ace Allen, MD, Protocol chair		Ph: 913-588-2251 Email: aallen@kumc.edu