A Phase II Trial of Trisenox in Women With Recurrent or Metastatic Endometrial Adenocarcinoma
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response (CR+PR) rate of subjects given Trisenox
To estimate the objective response (CR+PR) rate (as defined by the Gynecologic Oncology Group [GOG] RECIST Criteria)of Trisenox® in women with recurrent or metastatic endometrial cancer when administered at 0.25 mg/kg/day for 5 consecutive days (D1-5) every 4 weeks.
Paola Gehrig, MD
UNC Lineberger Comprehensive Cancer Center
United States: Institutional Review Board
|North Carolina Cancer Hosptial, UNC||Chapel Hill, North Carolina 27599|