Arsenic Trioxide in Treating Patients With Urothelial Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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PRIMARY OBJECTIVES: 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 cancer. OUTLINE: 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.

Official Title
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A PHASE II STUDY OF ARSENIC TRIOXIDE (NSC #706363, IND #57974) IN UROTHELIAL CANCER

Conditions
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Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter, Recurrent Urethral Cancer, Transitional Cell Carcinoma of the Bladder, Ureter Cancer

Intervention / Treatment
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* Drug: arsenic trioxide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (arsenic trioxide)<br>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. | Drug: arsenic trioxide<br>* Given IV<br>* Other names: Trisenox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response | 95% confidence intervals will be computed using binomial distribution. | Up to 2 years | 
| Toxicity graded using the CTC | Reported by type, frequency and severity. | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to disease progression | Estimated using the Kaplan-Meier method. | From the initiation of treatment to the date of progressive disease, assessed up to 2 years | 
| Duration of objective response | Estimated using the Kaplan-Meier method. | Up to 2 years |