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| ID | Type | Description | Link |
|---|---|---|---|
| CALGB-99903 | |||
| U10CA031946 | U.S. NIH Grant/Contract | View source |
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Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have recurrent cancer of the bladder or urinary tract. Arsenic trioxide may kill tumor cells that have become resistant to standard chemotherapy regimens.
PRIMARY OBJECTIVES:
I. To determine the efficacy of arsenic trioxide in patients with measurable urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.
II. To determine the toxicity of arsenic trioxide administered to patients with urothelial cancer.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (arsenic trioxide) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| arsenic trioxide | Drug | Given IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response | 95% confidence intervals will be computed using binomial distribution. | Up to 2 years |
| Toxicity graded using the CTC | Reported by type, frequency and severity. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to disease progression | Estimated using the Kaplan-Meier method. | From the initiation of treatment to the date of progressive disease, assessed up to 2 years |
| Duration of objective response |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dean Bajorin | Cancer and Leukemia Group B | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer and Leukemia Group B | Chicago | Illinois | 60606 | United States |
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| ID | Term |
|---|---|
| D014523 | Urethral Neoplasms |
| D014516 | Ureteral Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077237 | Arsenic Trioxide |
| ID | Term |
|---|---|
| D001152 | Arsenicals |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
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Estimated using the Kaplan-Meier method.
| Up to 2 years |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014522 | Urethral Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D014515 | Ureteral Diseases |