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Arsenic Trioxide in Treating Patients With Recurrent Bladder or Urinary Tract Cancer

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
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
Transitional Cell Cancer of the Renal Pelvis and Ureter
Urethral Cancer
Drug: arsenic trioxide
Phase II

Genetics Home Reference related topics:   bladder cancer   

MedlinePlus related topics:   Arsenic    Bladder Cancer    Cancer   

Drug Information available for:   Arsenic trioxide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase II Study Of Arsenic Trioxide (NSC #706363, IND #57974) In Urothelial Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   February 2001

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  Show 52 Study Locations

Sponsors and Collaborators
Cancer and Leukemia Group B
National Cancer Institute (NCI)

Investigators
Study Chair:     Dean F. Bajorin, MD     Memorial Sloan-Kettering Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000068419, CLB-99903
First Received:   February 2, 2001
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00009867
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent bladder cancer  
transitional cell carcinoma of the bladder  
recurrent urethral cancer  
recurrent transitional cell cancer of the renal pelvis and ureter  

Study placed in the following topic categories:
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Arsenic trioxide
Ureteral Diseases
Urogenital Neoplasms
Renal cancer
Kidney cancer
Carcinoma, Transitional Cell
Urologic Neoplasms
Transitional cell carcinoma
Recurrence
Carcinoma
Urethral cancer
Urologic Diseases
Kidney Neoplasms
Urethral Neoplasms
Kidney Diseases
Ureteral Neoplasms
Urinary tract neoplasm
Bladder neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Urethral Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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