Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00009867
Other study ID # NCI-2012-02789
Secondary ID CALGB-99903U10CA
Status Completed
Phase Phase 2
First received February 2, 2001
Last updated June 3, 2013
Start date December 2000

Study information

Verified date June 2013
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date
Est. primary completion date June 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
arsenic trioxide
Given IV

Locations

Country Name City State
United States Cancer and Leukemia Group B Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective response 95% confidence intervals will be computed using binomial distribution. Up to 2 years No
Primary Toxicity graded using the CTC Reported by type, frequency and severity. Up to 2 years Yes
Secondary Time to disease progression Estimated using the Kaplan-Meier method. From the initiation of treatment to the date of progressive disease, assessed up to 2 years No
Secondary Duration of objective response Estimated using the Kaplan-Meier method. Up to 2 years No
See also
  Status Clinical Trial Phase
Completed NCT02897765 - A Personal Cancer Vaccine (NEO-PV-01) w/ Nivolumab for Patients With Melanoma, Lung Cancer or Bladder Cancer Phase 1
Terminated NCT01118351 - Sunitinib Malate in Treating Patients With Recurrent Transitional Cell Bladder Cancer Phase 2
Terminated NCT00112905 - Sorafenib in Treating Patients With Regional or Metastatic Cancer of the Urothelium Phase 2
Completed NCT00072150 - Phase II Trial Of PS-341 (Bortezomib) In Patients With Previously Treated Advanced Urothelial Tract Transitional Cell Carcinoma Phase 2
Completed NCT00028756 - Comparison of Immediate and Delayed Adjuvant Chemotherapy in Treating Patients Who Have Undergone a Radical Cystectomy for Stage III or Stage IV Transitional Cell Carcinoma of the Bladder Urothelium Phase 3
Completed NCT02318329 - Open-Label, Dose-Finding Study Evaluating Safety and PK of FPA144 in Patients With Advanced Solid Tumors Phase 1
Completed NCT00407485 - VEGF Trap in Treating Patients With Recurrent, Locally Advanced, or Metastatic Cancer of the Urothelium Phase 2
Withdrawn NCT01639521 - Gemcitabine Hydrochloride and Cisplatin or High-Dose Methotrexate, Vinblastine, Doxorubicin Hydrochloride, and Cisplatin in Treating Patients With Urothelial Cancer Phase 2
Completed NCT00003167 - Gene Therapy in Treating Patients With Advanced Bladder Cancer Phase 1
Completed NCT03081858 - Proliposomal Intravesical Paclitaxel for Treatment of Low-Grade, Stage Ta, Non Muscle Invasive Bladder Cancer Phase 1/Phase 2
Completed NCT02101931 - A Laser Detection for Bladder Cancer by (Photodynamic) Spectra of Urine Phase 3
Terminated NCT00859339 - Neoadjuvant Cisplatin, Gemcitabine, Sunitinib Malate + Radical Cystectomy for TCC Phase 2
Completed NCT00005831 - Trastuzumab and Combination Chemotherapy in Treating Patients With Locally Recurrent or Metastatic Urinary Tract Cancer Phase 2
Completed NCT00706641 - Neoadjuvant Dasatinib and Radical Cystectomy for Transitional Cell Carcinoma of the Bladder N/A
Completed NCT01824329 - Prostate Capsule Sparing Cystectomy and Nerve-sparing Radical Cystoprostatectomy in Men With Bladder Cancer Phase 2
Terminated NCT00363883 - Vorinostat in Treating Patients With Locally Recurrent or Metastatic Cancer of the Urothelium Phase 2
Completed NCT00021099 - Ixabepilone in Treating Patients With Advanced Urinary Tract Cancer Phase 2
Terminated NCT01382706 - Docetaxel and Lapatinib in Metastatic Transitional Cell Carcinoma in Bladder Phase 2
Terminated NCT01954173 - Adjuvant Radiation for High Risk Bladder Cancer N/A
Terminated NCT00004856 - Trastuzumab in Treating Patients With Previously Treated, Locally Advanced, or Metastatic Cancer of the Urothelium Phase 2