Clinical trial · Interventional
Arsenic Trioxide in Treating Patients With Urothelial Cancer
A PHASE II STUDY OF ARSENIC TRIOXIDE (NSC #706363, IND #57974) IN UROTHELIAL CANCER
NCT00009867CI-TRIAL-00010541completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter | — | UNRESOLVED | — |
| Recurrent Urethral Cancer | Malignant Urethral Neoplasm | CURATED_BROADER | 0.80 |
| Transitional Cell Carcinoma of the Bladder | — | UNRESOLVED | — |
| Ureter Cancer | Malignant Ureter Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| arsenic trioxide | Drug | Arsenic Trioxide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (arsenic trioxide)
- description
- 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.
- interventionNames
- Drug: arsenic trioxide
Primary outcomes (2)
- measure
- Objective response
- timeFrame
- Up to 2 years
- description
- 95% confidence intervals will be computed using binomial distribution.
- measure
- Toxicity graded using the CTC
- timeFrame
- Up to 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.