Arsenic Trioxide in Treating Patients With Urothelial Cancer

Transitional Cell Carcinoma of the Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00009867
• Other study ID #: NCI-2012-02789
• Secondary ID: CALGB-99903U10CA
• Status: Completed
• Phase: Phase 2
• First received: February 2, 2001
• Last updated: June 3, 2013
• Start date: December 2000

Study information

• Verified date: June 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Transitional Cell
• Kidney Neoplasms
• Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter
• Recurrent Urethral Cancer
• Transitional Cell Carcinoma of the Bladder
• Ureter Cancer
• Ureteral Neoplasms
• Urinary Bladder Neoplasms

Intervention

Drug:
• arsenic trioxide
Given IV

Locations

Country	Name	City	State
United States	Cancer and Leukemia Group B	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response	95% confidence intervals will be computed using binomial distribution.	Up to 2 years	No
Primary	Toxicity graded using the CTC	Reported by type, frequency and severity.	Up to 2 years	Yes
Secondary	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	No
Secondary	Duration of objective response	Estimated using the Kaplan-Meier method.	Up to 2 years	No