Arsenic Trioxide in Treating Patients With Urothelial Cancer

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

arsenic trioxide

About this trial

This is an interventional treatment trial for Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cancer and Leukemia Group B

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (arsenic trioxide)

Arm Description

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.

Outcomes

Primary Outcome Measures

Objective response

95% confidence intervals will be computed using binomial distribution.

Toxicity graded using the CTC

Reported by type, frequency and severity.

Secondary Outcome Measures

Time to disease progression

Estimated using the Kaplan-Meier method.

Duration of objective response

Estimated using the Kaplan-Meier method.

Full Information

NCT ID

NCT00009867

First Posted

February 2, 2001

Last Updated

June 3, 2013

Sponsor

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00009867

Brief Title

Arsenic Trioxide in Treating Patients With Urothelial Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

December 2000 (undefined)

Primary Completion Date

June 2004 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Cancer Institute (NCI)

4. Oversight

5. 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter, Recurrent Urethral Cancer, Transitional Cell Carcinoma of the Bladder, Ureter Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment (arsenic trioxide)

Arm Type

Experimental

Arm Description

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 Type

Drug

Intervention Name(s)

arsenic trioxide

Other Intervention Name(s)

Arsenic (III) Oxide, Arsenic Sesquioxide, Arsenous Acid Anhydride, AS2O3, Trisenox

Intervention Description

Given IV

Primary Outcome Measure Information:

Title

Objective response

Description

95% confidence intervals will be computed using binomial distribution.

Time Frame

Up to 2 years

Title

Toxicity graded using the CTC

Description

Reported by type, frequency and severity.

Time Frame

Up to 2 years

Secondary Outcome Measure Information:

Title

Time to disease progression

Description

Estimated using the Kaplan-Meier method.

Time Frame

From the initiation of treatment to the date of progressive disease, assessed up to 2 years

Title

Duration of objective response

Description

Estimated using the Kaplan-Meier method.

Time Frame

Up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dean Bajorin

Organizational Affiliation

Cancer and Leukemia Group B

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cancer and Leukemia Group B

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60606

Country

United States

Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter, Recurrent Urethral Cancer, Transitional Cell Carcinoma of the Bladder

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial