Arsenic Trioxide in Treating Patients With Urothelial Cancer

NCT00009867 | Completed Phase 2

• 3 other identifiers: NCI-2012-02789CALGB-99903U10CA031946
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter; Recurrent Urethral Cancer; Transitional Cell Carcinoma of the Bladder; Ureter Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Time to disease progression

  From the initiation of treatment to the date of progressive disease, assessed up to 2 years

• Duration of objective response

  Up to 2 years

Study Arms (1)

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.

Drug: arsenic trioxide

Interventions

arsenic trioxide DRUG

Given IV

Also known as: Arsenic (III) Oxide, Arsenic Sesquioxide, Arsenous Acid Anhydride, AS2O3, Trisenox

Treatment (arsenic trioxide)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Cancer and Leukemia Group B

Chicago, Illinois, 60606, United States

Location

MeSH Terms

Conditions

Urethral Neoplasms; Ureteral Neoplasms

Interventions

Arsenic Trioxide

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urethral Diseases; Urologic Diseases; Male Urogenital Diseases; Ureteral Diseases

Intervention Hierarchy (Ancestors)

Arsenicals; Inorganic Chemicals; Oxides; Oxygen Compounds

Study Officials

• Dean Bajorin

  Cancer and Leukemia Group B

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2001
• First Posted: December 31, 2003
• Study Start: December 1, 2000
• Primary Completion: June 1, 2004
• Last Updated: June 4, 2013

Record last verified: 2013-06

Locations

US (1)