Trisenox® in Women With Metastatic Endometrial Cancer
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Trisenox in Women With Recurrent or Metastatic Endometrial Adenocarcinoma|
- Objective response (CR+PR) rate of subjects given Trisenox [ Time Frame: 2 years ] [ Designated as safety issue: No ]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.
- Safety of Trisenox® [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Any patient who receives at least one dose of Trisenox® on this protocol will be evaluable for toxicity. Safety will be assessed by routine physical, laboratory and ECG evaluations. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting.
- Progression free survival, and overall survival in patients treated with Trisenox® [ Time Frame: 2 years ] [ Designated as safety issue: No ]Progression-Free survival is the period from start of treatment until disease progression, death, or date of last contact.
- Duration of response [ Time Frame: 2 years ] [ Designated as safety issue: No ]Patients will have target lesions assessed. These lesions will be identified and will be re-evaluated every even cycle (cycle 2, cycle 4, cycle 6, etc)
- Associations between markers of angiogenesis (e.g. VEGF) with response [ Time Frame: 4 years ] [ Designated as safety issue: No ]We will request a blood sample to measure vascular endothelial growth factor (VEGF) as well as other angiogenic factors and correlate levels to response to arsenic trioxide. Such effects have been observed in cultured cell lines and animal models, as well as clinical studies.
|Study Start Date:||March 2010|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
|Experimental: Trisenox treatment||
Drug: Arsenic trioxide
Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
Other Name: Trisonex
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01184053
|United States, North Carolina|
|North Carolina Cancer Hosptial, UNC|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Paola Gehrig, MD||UNC Lineberger Comprehensive Cancer Center|