Arsenic Trioxide in Treating Patients With Urothelial Cancer
Completed · Phase 2
Conditions studied: Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter, Recurrent Urethral Cancer, Transitional Cell Carcinoma of the Bladder, Ureter Cancer
In brief
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.
Key facts
- Study ID
- NCT00009867
- Run by
- National Cancer Institute (NCI)
- People needed
- 35
- Starts
- 2000-12-01
- Last updated by the study team
- 2013-06-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Cancer and Leukemia Group B — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.