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Arsenic Trioxide in Treating Patients With Urothelial Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00009867
First Posted: December 31, 2003
Last Update Posted: June 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
  Purpose
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.

Condition Intervention Phase
Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter Recurrent Urethral Cancer Transitional Cell Carcinoma of the Bladder Ureter Cancer Drug: arsenic trioxide Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PHASE II STUDY OF ARSENIC TRIOXIDE (NSC #706363, IND #57974) IN UROTHELIAL CANCER

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response [ Time Frame: Up to 2 years ]
    95% confidence intervals will be computed using binomial distribution.

  • Toxicity graded using the CTC [ Time Frame: Up to 2 years ]
    Reported by type, frequency and severity.


Secondary Outcome Measures:
  • Time to disease progression [ Time Frame: From the initiation of treatment to the date of progressive disease, assessed up to 2 years ]
    Estimated using the Kaplan-Meier method.

  • Duration of objective response [ Time Frame: Up to 2 years ]
    Estimated using the Kaplan-Meier method.


Enrollment: 35
Study Start Date: December 2000
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00009867


Locations
United States, Illinois
Cancer and Leukemia Group B
Chicago, Illinois, United States, 60606
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Dean Bajorin Cancer and Leukemia Group B
  More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00009867     History of Changes
Other Study ID Numbers: NCI-2012-02789
CALGB-99903
U10CA031946 ( U.S. NIH Grant/Contract )
First Submitted: February 2, 2001
First Posted: December 31, 2003
Last Update Posted: June 4, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Carcinoma, Transitional Cell
Urethral Neoplasms
Urinary Bladder Neoplasms
Kidney Neoplasms
Ureteral Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urethral Diseases
Urologic Diseases
Urinary Bladder Diseases
Kidney Diseases
Ureteral Diseases
Arsenic trioxide
Antineoplastic Agents