Arsenic Trioxide in Treating Patients With Urothelial Cancer

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00009867

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter Recurrent Urethral Cancer Transitional Cell Carcinoma of the Bladder Ureter Cancer	Drug: arsenic trioxide	Phase 2

Detailed Description

PRIMARY OBJECTIVES:

To determine the efficacy of arsenic trioxide in patients with measurable urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.
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.

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2000

Actual Primary Completion Date :

Jun 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment (arsenic trioxide) 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 Given IV Other Names: Arsenic (III) Oxide Arsenic Sesquioxide Arsenous Acid Anhydride AS2O3 Trisenox

Arm

Intervention/Treatment

Experimental: Treatment (arsenic trioxide)

Drug: arsenic trioxide

Given IV

Other Names:

Arsenic (III) Oxide

Arsenic Sesquioxide

Arsenous Acid Anhydride

AS2O3

Trisenox

Outcome Measures

Primary Outcome Measures

Objective response [Up to 2 years]
95% confidence intervals will be computed using binomial distribution.
Toxicity graded using the CTC [Up to 2 years]
Reported by type, frequency and severity.

Secondary Outcome Measures

Time to disease progression [From the initiation of treatment to the date of progressive disease, assessed up to 2 years]
Estimated using the Kaplan-Meier method.
Duration of objective response [Up to 2 years]
Estimated using the Kaplan-Meier method.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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