Arsenic Trioxide in Treating Patients With Urothelial Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Arsenic Trioxide

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