Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	OSU-88HO063 NCI-T88-0093D, T88-0093

Objectives

I.  Evaluate the response rate of unresectable bladder carcinoma in patients 
treated with amonafide.
II.  Assess the qualitative and quantitative toxicities of amonafide in a 
Phase II trial.
III.  Study the metabolism and pharmacokinetics of amonafide in humans.

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, bidimensionally measurable unresectable local or 
metastatic carcinoma of the bladder.  Eligible histologies include 
transitional cell carcinoma and mixed histologies that include transitional 
cell.  One prior chemotherapy regimen is allowed; at least 4 weeks must have 
elapsed since any prior chemotherapy, and patients must have fully recovered 
from any toxicity.  Prior radiotherapy and surgery are also permitted, but at 
least 4 weeks must have elapsed since any radiotherapy.  Patients may not 
receive concomitant hormonal or cytotoxic therapy.  Concurrent palliative 
radiotherapy is allowed to lesions as long as they do not represent the site 
of measurable disease.  A life expectancy of at least 8 weeks and a Zubrod 
performance status of 0-2 are required.  Patients must have near normal bone 
marrow function (WBC greater than 3,000, absolute granulocytes greater than 
1,500, and platelets greater than 100,000), serum creatinine and serum 
bilirubin each less than 1.5 mg/dl, and SGOT less than 2 times the upper limit 
of normal.  Pregnant women are not eligible, and women of childbearing age 
will be encouraged to practice contraception.

Expected Enrollment

If one or more responses are observed in the first 14 evaluable patients, 
accrual will continue until 25 patients are evaluable.

Outline

Nonrandomized study.
Single-agent Chemotherapy.  Amonafide, NSC-308847.

Trial Contact Information

Trial Lead Organizations

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Pierre Triozzi, MD, Protocol chair(Contact information may not be current)		Ph: 205-975-7162