|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| 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 |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Study Of Arsenic Trioxide (NSC #706363, IND #57974) In Urothelial Cancer |
| Study Start Date: | 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.
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 |
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![]() |
Show 52 Study Locations |
| Cancer and Leukemia Group B |
| National Cancer Institute (NCI) |
| Study Chair: | Dean F. Bajorin, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| 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 |
|
|
|
|
|