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


Phase 2
18 Years
N/A
Not Enrolling
Both
Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter, Recurrent Urethral Cancer, Transitional Cell Carcinoma of the Bladder, Ureter Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response

Outcome Description:

95% confidence intervals will be computed using binomial distribution.

Outcome Time Frame:

Up to 2 years

Safety Issue:

No

Principal Investigator

Dean Bajorin

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02789

NCT ID:

NCT00009867

Start Date:

December 2000

Completion Date:

Related Keywords:

  • Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Recurrent Urethral Cancer
  • Transitional Cell Carcinoma of the Bladder
  • Ureter Cancer
  • Urinary Bladder Neoplasms
  • Carcinoma
  • Carcinoma, Transitional Cell
  • Ureteral Neoplasms
  • Urethral Neoplasms
  • Kidney Neoplasms

Name

Location

Cancer and Leukemia Group BChicago, Illinois  60606