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Arsenic Trioxide

Trisenox treatment for Uterine Cancer (NRR Trial)

Phase 2
Waitlist Available
Led By Paola Gehrig, MD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

The primary purpose of this study is to see whether women who have already received chemotherapy for their endometrial cancer, or who have disease that has spread outside of the uterus, will respond to the drug arsenic trioxide (Trisenox®) as judged by shrinkage of their tumor.

Eligible Conditions
  • Uterine Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Response (CR+PR) Rate of Subjects Given Trisenox
Secondary study objectives
Associations Between Markers of Angiogenesis (e.g. VEGF) With Response
Progression Free Survival in Patients Treated With Trisenox®

Side effects data

From 2009 Phase 2 trial • 22 Patients • NCT00024258
18%
Bone pain
18%
Infection NOS
18%
Infection w/o neutropenia
14%
Constipation
14%
Edema
14%
Nausea
14%
Pain, other
14%
Vomiting
14%
Neutrophil count decrease
14%
Cough
14%
Anemia
9%
Anorexia
9%
Gastrointestinal other
9%
Anxiety
9%
Platelet count decreased
9%
Respiratory, thoracic and mediastinal disorders - Other, specify Respiratory disorder
9%
Tumor pain
9%
Dyspnea
9%
Fever
9%
Neutrophil count decreased
5%
Febrile Neutropenia
5%
Catheter related infection
5%
Hypertension
5%
Renal failure
5%
Blood bilirubin increased
5%
Bruising
5%
Conjunctivitis
5%
Neurology, other
5%
Hyperkalemia
5%
Hypocalcemia
5%
Electrocardiogram QT corrected interval prolonged
5%
Hyperglycemia
5%
White blood cell decreased
5%
Purpura
5%
Pleural effusion
5%
Alanine aminotransferase increased
5%
Sinus tachycardia
5%
Urinary retention
5%
Weight loss
5%
Dry Eye
5%
Dehydration
5%
Hypercalcemia
5%
Neuralgia
5%
Fatigue
5%
Mucositis
5%
Aspartate aminotransferase increased
5%
Hypermagnesemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arsenic Trioxide

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Trisenox treatmentExperimental Treatment1 Intervention
Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Arsenic trioxide
FDA approved

Find a Location

Who is running the clinical trial?

CephalonIndustry Sponsor
156 Previous Clinical Trials
18,852 Total Patients Enrolled
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
364 Previous Clinical Trials
92,381 Total Patients Enrolled
Paola Gehrig, MDPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center
~0 spots leftby Nov 2025
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