Arsenic Trioxide in Treating Patients With Urothelial Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00009867
First received: February 2, 2001
Last updated: June 3, 2013
Last verified: June 2013

February 2, 2001
June 3, 2013
December 2000
June 2004   (final data collection date for primary outcome measure)
  • Objective response [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    95% confidence intervals will be computed using binomial distribution.
  • Toxicity graded using the CTC [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
    Reported by type, frequency and severity.
Not Provided
Complete list of historical versions of study NCT00009867 on ClinicalTrials.gov Archive Site
  • Time to disease progression [ Time Frame: From the initiation of treatment to the date of progressive disease, assessed up to 2 years ] [ Designated as safety issue: No ]
    Estimated using the Kaplan-Meier method.
  • Duration of objective response [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Estimated using the Kaplan-Meier method.
Not Provided
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Recurrent Urethral Cancer
  • Transitional Cell Carcinoma of the Bladder
  • Ureter Cancer
Drug: arsenic trioxide
Given IV
Other Names:
  • Arsenic (III) Oxide
  • Arsenic Sesquioxide
  • Arsenous Acid Anhydride
  • AS2O3
  • Trisenox
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.
Intervention: Drug: arsenic trioxide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
Not Provided
June 2004   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00009867
NCI-2012-02789, CALGB-99903, U10CA031946
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Dean Bajorin Cancer and Leukemia Group B
National Cancer Institute (NCI)
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP