Arsenic Trioxide in Treating Patients With Urothelial Cancer

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00009867
Collaborator
(none)
35
Enrollment
1
Location
1
Arm

Study Details

Study Description

Brief 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:
  1. To determine the efficacy of arsenic trioxide in patients with measurable urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.

  2. 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 Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
N/A
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
Study Start Date :
Dec 1, 2000
Actual Primary Completion Date :
Jun 1, 2004

Arms and Interventions

ArmIntervention/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
  • Outcome Measures

    Primary Outcome Measures

    1. Objective response [Up to 2 years]

      95% confidence intervals will be computed using binomial distribution.

    2. Toxicity graded using the CTC [Up to 2 years]

      Reported by type, frequency and severity.

    Secondary Outcome Measures

    1. Time to disease progression [From the initiation of treatment to the date of progressive disease, assessed up to 2 years]

      Estimated using the Kaplan-Meier method.

    2. Duration of objective response [Up to 2 years]

      Estimated using the Kaplan-Meier method.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    SiteCityStateCountryPostal Code
    1Cancer and Leukemia Group BChicagoIllinoisUnited States60606

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Dean Bajorin, Cancer and Leukemia Group B

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00009867
    Other Study ID Numbers:
    • NCI-2012-02789
    • CALGB-99903
    • U10CA031946
    First Posted:
    Dec 31, 2003
    Last Update Posted:
    Jun 4, 2013
    Last Verified:
    Jun 1, 2013

    Study Results

    No Results Posted as of Jun 4, 2013