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 no age specified NCI WSU-C-52883 NCI-T83-1413C, T83-1413

Objectives

I.  Determine the response rate and duration of response among patients with 
metastatic renal carcinoma treated with 4'-deoxydoxorubicin on a 3-4 week 
schedule.
II.  Further delineate the toxicities associated with this agent.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with measurable metastatic 
adenocarcinoma of the kidney proven histologically, or, when that is not 
possible, with a compatible renal angiogram or computerized tomography.  There 
may have been no prior chemotherapy, and patients must not have had 
radiotherapy within 4 weeks of entry and must have recovered from the toxic 
effects of that treatment.  Patients must have an expected survival of at 
least 6 weeks and a Karnofsky performance status of at least 50 percent.  
Liver and bone marrow function must be normal.  There must be no history of 
cardiac disease, and the baseline MUGA and/or echocardiogram should 
demonstrate normal left ventricular function.

Expected Enrollment

If there are any responses among the first 14 patients entered, accrual will 
continue until at least 25 evaluable patients have been entered.

Outline

Nonrandomized study.
Single-agent Chemotherapy.  4'-Deoxydoxorubicin, NSC-267469.

Kish JA, Ensley JF, al-Sarraf M: Phase II evaluation of 4'deoxydoxorubicin in advanced renal cell carcinoma. Am J Clin Oncol 13 (1): 17-8, 1990.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Barbara Ann Karmanos Cancer Institute

Julie Kish, MD, FACP, Protocol chair		Ph: 813-745-3822; 888-663-3488