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

This study is no longer recruiting patients.

Sponsors and Collaborators: National Cancer Institute (NCI)
Cancer and Leukemia Group B
Information provided by: National Cancer Institute (NCI)


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 Treatment or Intervention Phase
recurrent urethral cancer
transitional cell carcinoma of the bladder
recurrent bladder cancer
recurrent transitional cell cancer of the renal pelvis and ureter
 Procedure: chemotherapy
 Drug: arsenic trioxide
Phase II

MedlinePlus related topics:  Bladder Cancer;   Cancer;   Kidney Cancer
Genetics Home Reference related topics:  bladder cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Arsenic Trioxide in Patients With Recurrent Urothelial Cancer

Further Study Details: 

Study start: February 2001

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.

PROTOCOL 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.


Ages Eligible for Study:  18 Years and above



--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

--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

--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

Location Information

      Veterans Affairs Medical Center - Birmingham, Birmingham,  Alabama,  35233-1996,  United States

      UCSF Cancer Center and Cancer Research Institute, San Francisco,  California,  94143-0128,  United States

      University of California San Diego Cancer Center, La Jolla,  California,  92093-0658,  United States

      Veterans Affairs Medical Center - San Francisco, San Francisco,  California,  94121,  United States

      CCOP - Christiana Care Health Services, Wilmington,  Delaware,  19899,  United States

District of Columbia
      Lombardi Cancer Center, Washington,  District of Columbia,  20007,  United States

      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5000,  United States

      CCOP - Mount Sinai Medical Center, Miami Beach,  Florida,  33140,  United States

      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States

      University of Illinois at Chicago Health Sciences Center, Chicago,  Illinois,  60612,  United States

      Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago,  Illinois,  60612,  United States

      CCOP - Northern Indiana CR Consortium, South Bend,  Indiana,  46601,  United States

      Hematology Oncology Associates of the Quad Cities, Bettendorf,  Iowa,  52722,  United States

      Holden Comprehensive Cancer Center at The University of Iowa, Iowa City,  Iowa,  52242-1009,  United States

      Veterans Affairs Medical Center - Togus, Togus,  Maine,  04330,  United States

      Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore,  Maryland,  21201,  United States

      Dana-Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States

      University of Massachusetts Memorial Medical Center, Worcester,  Massachusetts,  01655,  United States

      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States

      Veterans Affairs Medical Center - Minneapolis, Minneapolis,  Minnesota,  55417,  United States

      Barnes-Jewish Hospital, Saint Louis,  Missouri,  63110,  United States

      Ellis Fischel Cancer Center - Columbia, Columbia,  Missouri,  65203,  United States

      Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia,  Missouri,  65201,  United States

      University of Nebraska Medical Center, Omaha,  Nebraska,  68198-3330,  United States

      CCOP - Southern Nevada Cancer Research Foundation, Las Vegas,  Nevada,  89106,  United States

New Hampshire
      Norris Cotton Cancer Center, Lebanon,  New Hampshire,  03756-0002,  United States

New York
      CCOP - North Shore University Hospital, Manhasset,  New York,  11030,  United States

      CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse,  New York,  13217,  United States

      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

      Mount Sinai Medical Center, NY, New York,  New York,  10029,  United States

      New York Presbyterian Hospital - Cornell Campus, New York,  New York,  10021,  United States

      North Shore University Hospital, Manhasset,  New York,  11030,  United States

      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States

      State University of New York - Upstate Medical University, Syracuse,  New York,  13210,  United States

      Veterans Affairs Medical Center - Buffalo, Buffalo,  New York,  14215,  United States

      Veterans Affairs Medical Center - Syracuse, Syracuse,  New York,  13210,  United States

North Carolina
      CCOP - Southeast Cancer Control Consortium, Winston Salem,  North Carolina,  27104-4241,  United States

      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1082,  United States

      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States

      Lineberger Comprehensive Cancer Center, UNC, Chapel Hill,  North Carolina,  27599-7295,  United States

      Veterans Affairs Medical Center - Durham, Durham,  North Carolina,  27705,  United States

      Arthur G. James Cancer Hospital - Ohio State University, Columbus,  Ohio,  43210-1240,  United States

Rhode Island
      Rhode Island Hospital, Providence,  Rhode Island,  02903,  United States

South Carolina
      CCOP - Greenville, Greenville,  South Carolina,  29615,  United States

      Medical University of South Carolina, Charleston,  South Carolina,  29425-0721,  United States

      University of Tennessee, Memphis Cancer Center, Memphis,  Tennessee,  38103,  United States

      Veterans Affairs Medical Center - Memphis, Memphis,  Tennessee,  38104,  United States

      CCOP - Southwestern Vermont Regional Cancer Center, Bennington,  Vermont,  05201,  United States

      Vermont Cancer Center, Burlington,  Vermont,  05401-3498,  United States

      Veterans Affairs Medical Center - White River Junction, White River Junction,  Vermont,  05009,  United States

      MBCCOP - Massey Cancer Center, Richmond,  Virginia,  23298-0037,  United States

      Veterans Affairs Medical Center - Richmond, Richmond,  Virginia,  23249,  United States

Study chairs or principal investigators

Dean F Bajorin,  Study Chair,  Cancer and Leukemia Group B   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068419; CLB-99903
Record last reviewed:  December 2003
Last Updated:  October 13, 2004
Record first received:  February 2, 2001 Identifier:  NCT00009867
Health Authority: United States: Federal Government processed this record on 2005-04-08

Cache Date: April 9, 2005