Arsenic Trioxide in Treating Patients With Urothelial Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter; Transitional Cell Carcinoma of the Bladder; Ureter Cancer; Recurrent Urethral Cancer
• Intervention / Treatment: Drug: arsenic trioxide

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60606
      • Cancer and Leukemia Group B

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Dean Bajorin, Cancer and Leukemia Group B

Study record dates

Study Major Dates

• Study Start: December 1, 2000
• Primary Completion (ACTUAL): June 1, 2004

Study Registration Dates

• First Submitted: February 2, 2001
• First Submitted That Met QC Criteria: December 30, 2003
• First Posted (ESTIMATE): December 31, 2003

Study Record Updates

• Last Update Posted (ESTIMATE): June 4, 2013
• Last Update Submitted That Met QC Criteria: June 3, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Urinary Bladder Diseases; Disease Attributes; Ureteral Diseases; Urethral Diseases; Recurrence; Urinary Bladder Neoplasms; Carcinoma, Transitional Cell; Ureteral Neoplasms; Urethral Neoplasms; Antineoplastic Agents; Arsenic Trioxide
• Other Study ID Numbers: NCI-2012-02789; U10CA031946 (U.S. NIH Grant/Contract); CALGB-99903