Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have
recurrent cancer of the bladder or urinary tract. Arsenic trioxide may kill tumor cells that
have become resistant to standard chemotherapy regimens.
I. To determine the efficacy of arsenic trioxide in patients with measurable urothelial
carcinoma of the bladder, urethra, ureter, or renal pelvis.
II. To determine the toxicity of arsenic trioxide administered to patients with urothelial
Patients receive arsenic trioxide IV over 1 hour on days 1-5. Treatment repeats every 28
days for a minimum of 2 courses in the absence of disease progression or unacceptable
toxicity. Patients who achieve complete response receive 2 additional courses.
Patients are followed every 2 months for 1 year after registration and then every 6 months
for 1 year or until disease progression or relapse.
- Diagnosis of transitional cell carcinoma of the bladder, urethra, ureter or renal
pelvis; histologic documentation of metastatic/recurrent disease is not required;
clinical staging, but not pathological staging, is required
- Patients must have relapsed from or failed to achieve a complete or partial response
after one chemotherapy regimen, which must have included one of the following
chemotherapy agents: cisplatin, carboplatin paclitaxel, or gemcitabine
- >= 4 weeks since prior RT or chemotherapy
- Patients must have measurable disease
- CTC (ECOG) Performance Status =< 1
- No evidence of NYHA functional class III or IV heart disease
- Baseline EKG with QTc < 500 ms
- Non-pregnant and not nursing, as chemotherapy is thought to present substantial risk
to the fetus/infant; men and women of reproductive potential may not participate
unless they have agreed to use an effective contraceptive method while in this study
- Granulocytes > 1500/ml
- Platelet count > 100,000/ml
- Bilirubin =< Upper limits of normal (ULN)
- Serum Creatinine < 2.0 x ULN