Full Text View
Tabular View
No Study Results Posted
Related Studies
Arsenic Trioxide in Treating Patients With Recurrent Bladder or Urinary Tract Cancer
This study has been completed.
Study NCT00009867   Information provided by National Cancer Institute (NCI)
First Received: February 2, 2001   Last Updated: October 15, 2009   History of Changes

February 2, 2001
October 15, 2009
February 2001
July 2009   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00009867 on ClinicalTrials.gov Archive Site
 
 
 
Arsenic Trioxide in Treating Patients With Recurrent Bladder or Urinary Tract Cancer
A Phase II Study Of Arsenic Trioxide (NSC #706363, IND #57974) In Urothelial Cancer

RATIONALE: Arsenic trioxide may kill tumor cells that have become resistant to standard chemotherapy regimens.

PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have recurrent cancer of the bladder or urinary tract.

OBJECTIVES: I. Determine the efficacy of arsenic trioxide in patients with recurrent urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis. II. Determine the toxicity of this drug in these patients.

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.

PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 12-18 months.

Phase II
Interventional
Treatment
  • Bladder Cancer
  • Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Urethral Cancer
Drug: arsenic trioxide
 
Bajorin DF, Halabi S, Small E. Arsenic Trioxide in Recurrent Urothelial Cancer: A Cancer and Leukemia Group B Phase II Trial (CALGB 99903). Clin Genitourin Cancer. 2009 Oct 1;7(3):E66-E70.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
July 2009   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS: Histologically confirmed transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis Histologic documentation of metastatic or recurrent disease is not required Clinical (not pathological) staging is required Measurable disease At least 20 mm by conventional techniques OR At least 10 mm by spiral CT scan Nonmeasurable disease defined as any of the following: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Lymphangitis cutis/pulmonis Abdominal masses not confirmed or followed by imaging techniques Cystic lesions Primary bladder masses Relapse from or failure to achieve complete or partial response after 1 chemotherapy regimen that included cisplatin, carboplatin, paclitaxel, or gemcitabine

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Granulocyte count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) Renal: Creatinine less than 2 times ULN Cardiovascular: No New York Heart Association class III or IV heart disease Electrocardiogram QTc less than 500 msec Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other concurrent active malignancy (greater than 30% risk of relapse) except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy except for non-disease related conditions (e.g., insulin for diabetes) and steroids for adrenal failure Radiotherapy: Prior palliative radiotherapy allowed for symptomatic lesions or in case of disability (e.g., unstable femur) provided other measurable disease is present At least 4 weeks since prior radiotherapy No concurrent palliative radiotherapy Surgery: Not specified

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00009867
 
CDR0000068419, CLB-99903
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Study Chair: Dean F. Bajorin, MD Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP