NCT01184053

Trisenox® in Women With Metastatic Endometrial Cancer

A Phase II Trial of Trisenox in Women With Recurrent or Metastatic Endometrial Adenocarcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an open-label, single arm, single institution, phase II trial designed to assess the response rate and safety of Trisenox® in women with recurrent endometrial carcinoma. Trisenox® will be administered at a dose of 0.25 mg/kg/day for 5 consecutive days (D1-5) every 4 weeks. A 4-week period will be defined as a cycle of treatment. Marker and non-marker lesions will be assessed every 2 cycles (every 8 weeks) and the response assigned according to Gynecologic Oncology Group (GOG) RECIST guidelines. Safety will be assessed by routine physical, laboratory and ECG evaluations. Up to 10 patients will be enrolled into the study. Patients are expected (excluding any unforeseen toxicities) to receive a minimum of 2 and a maximum of 6 cycles of Trisenox®. (Patients with at least documented stable disease may be eligible for \>6 cycles). Patients will be followed for 6 months after their last dose of Trisenox®. For this trial we would allow one prior cytotoxic regimen since the time of recurrence and patients may have had one prior regimen as part of their induction chemotherapy. Patients will be treated with 0.25 mg/kg/day for days 1-5 every 28 days and patients may remain on trial until progression of disease.

Conditions

• Endometrial Carcinoma

Interventions

Type	Name	Description
DRUG	Arsenic trioxide	Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2010-08-18
• Last updated: 2017-06-14
• Results posted: 2017-06-14

Locations

1 site across 1 country: United States