Arsenic Trioxide in Treating Patients With Urothelial Cancer

National Cancer Institute (NCI)

Status and phase: Completed; Phase 2

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

Treatments: Drug: arsenic trioxide

Study type: Interventional

Funder types: NIH

Identifiers

NCT00009867

CALGB-99903

NCI-2012-02789

U10CA031946 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Treatment (arsenic trioxide)

Experimental group

Description:

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.

Treatment:

Drug: arsenic trioxide