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Arsenic Trioxide in Treating Patients With Recurrent Bladder or Urinary Tract Cancer
This study has been completed.

First Received on February 2, 2001.   Last Updated on April 1, 2011   History of Changes
Sponsor: Cancer and Leukemia Group B
Collaborator: National Cancer Institute (NCI)
Information provided by: Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT00009867
  Purpose

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.


Condition Intervention Phase
Bladder Cancer
Renal Pelvis and Ureter Urothelial Carcinoma
Urethral Cancer
Drug: arsenic trioxide
Phase II

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Of Arsenic Trioxide (NSC #706363, IND #57974) In Urothelial Cancer

Resource links provided by NLM:


Further study details as provided by Cancer and Leukemia Group B:

Primary Outcome Measures:
  • Objective Response [ Time Frame: Every 2 cycles (8 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: q 2 mon 1 yr after registration, then q 6 mon ] [ Designated as safety issue: Yes ]
  • Time to disease progression [ Time Frame: q 2 months 1 yr after registration, then q 6 mon ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: q 2 mon 1 yr after registration, then q 6 mon ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: February 2001
Study Completion Date: April 2009
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arsenic trioxide
Use of arsenic trioxide in treatment of patients with urothelial cancer
Drug: arsenic trioxide
0.3 mg/kg/day IV infusion in 5% dextrose over 1 hour daily for 5 days, followed by 3 weeks rest

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00009867

  Show 52 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Dean F. Bajorin, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: Monica M Bertagnolli, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT00009867     History of Changes
Other Study ID Numbers: CDR0000068419, U10CA031946, CLB-99903
Study First Received: February 2, 2001
Last Updated: April 1, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Cancer and Leukemia Group B:
recurrent bladder cancer
transitional cell carcinoma of the bladder
recurrent urethral cancer
recurrent transitional cell cancer of the renal pelvis and ureter

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma
Carcinoma, Transitional Cell
Urethral Neoplasms
Kidney Neoplasms
Ureteral Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urethral Diseases
Kidney Diseases
Ureteral Diseases
Arsenic trioxide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012