Clinical trial NCT00009867: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter
Recurrent Urethral Cancer
Transitional Cell Carcinoma of the Bladder
Ureter Cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-12-31
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Objective response
timeFrame: Up to 2 years
measure: Toxicity graded using the CTC
timeFrame: Up to 2 years
Secondary outcomes:
measure: Time to disease progression
timeFrame: From the initiation of treatment to the date of progressive disease, assessed up to 2 years
measure: Duration of objective response
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Cancer and Leukemia Group B
state: Illinois
Study officials:
affiliation: Cancer and Leukemia Group B
name: Dean Bajorin
role: PRINCIPAL_INVESTIGATOR
References: