Trials / Completed
CompletedNCT00009867
Arsenic Trioxide in Treating Patients With Urothelial Cancer
A PHASE II STUDY OF ARSENIC TRIOXIDE (NSC #706363, IND #57974) IN UROTHELIAL CANCER
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter
- Recurrent Urethral Cancer
- Transitional Cell Carcinoma of the Bladder
- Ureter Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | arsenic trioxide | Given IV |
Timeline
- Start date
- 2000-12-01
- Primary completion
- 2004-06-01
- First posted
- 2003-12-31
- Last updated
- 2013-06-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00009867. Inclusion in this directory is not an endorsement.