Arsenic Trioxide in Treating Patients With Urothelial Cancer
This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00009867
First received: February 2, 2001
Last updated: January 7, 2013
Last verified: December 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter Recurrent Urethral Cancer Transitional Cell Carcinoma of the Bladder Ureter Cancer |
Drug: arsenic trioxide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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 National Cancer Institute (NCI):
Primary Outcome Measures:
- Objective response [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]95% confidence intervals will be computed using binomial distribution.
- Toxicity graded using the CTC [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]Reported by type, frequency and severity.
Secondary Outcome Measures:
- Time to disease progression [ Time Frame: From the initiation of treatment to the date of progressive disease, assessed up to 2 years ] [ Designated as safety issue: No ]Estimated using the Kaplan-Meier method.
- Duration of objective response [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]Estimated using the Kaplan-Meier method.
| Enrollment: | 35 |
| Study Start Date: | December 2000 |
| Primary Completion Date: | June 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (arsenic trioxide)
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.
|
Drug: arsenic trioxide
Given IV
Other Names:
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of transitional cell carcinoma of the bladder, urethra, ureter or renal pelvis; histologic documentation of metastatic/recurrent disease is not required; clinical staging, but not pathological staging, is required
- Patients must have relapsed from or failed to achieve a complete or partial response after one chemotherapy regimen, which must have included one of the following chemotherapy agents: cisplatin, carboplatin paclitaxel, or gemcitabine
- >= 4 weeks since prior RT or chemotherapy
- Patients must have measurable disease
- CTC (ECOG) Performance Status =< 1
- No evidence of NYHA functional class III or IV heart disease
- Baseline EKG with QTc < 500 ms
- Non-pregnant and not nursing, as chemotherapy is thought to present substantial risk to the fetus/infant; men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while in this study
- Granulocytes > 1500/ml
- Platelet count > 100,000/ml
- Bilirubin =< Upper limits of normal (ULN)
- Serum Creatinine < 2.0 x ULN
Contacts and Locations More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00009867 History of Changes |
| Other Study ID Numbers: | NCI-2012-02789, CALGB-99903, U10CA031946, CDR0000068419 |
| Study First Received: | February 2, 2001 |
| Last Updated: | January 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Carcinoma Carcinoma, Transitional Cell Ureteral Neoplasms Urethral Neoplasms Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases |
Urologic Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Ureteral Diseases Urethral Diseases Kidney Diseases Arsenic trioxide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013