Arsenic Trioxide in Treating Patients With Urothelial Cancer

Phase 2

Completed

• Conditions: Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter; Recurrent Urethral Cancer; Transitional Cell Carcinoma of the Bladder; Ureter Cancer
• Interventions: Drug: arsenic trioxide

• Registration Number: NCT00009867
• Lead Sponsor: National Cancer Institute (NCI)

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.

Detailed Description

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.

Study Timeline

• Study Start: 2000-12
• Study First Submitted: 2001-02-02
• Study First Submitted QC: 2003-12-30
• Study First Posted: 2003-12-31
• Primary Completion: 2004-06
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-03
• Last Update Posted: 2013-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (arsenic trioxide)	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Cancer and Leukemia Group B; 🇺🇸 Chicago, Illinois, United States