Trisenox® in Women With Metastatic Endometrial Cancer (NRR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01184053
Recruitment Status : Terminated (Accrual was very low. No subject had been enrolled in a year.)
First Posted : August 18, 2010
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Endometrial Carcinoma Drug: Arsenic trioxide Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Trisenox in Women With Recurrent or Metastatic Endometrial Adenocarcinoma
Study Start Date : March 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arsenic
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Trisenox treatment
Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
Drug: Arsenic trioxide
Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
Other Name: Trisenox

Primary Outcome Measures :
  1. Objective Response (CR+PR) Rate of Subjects Given Trisenox [ Time Frame: 28 days ]
    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.

Secondary Outcome Measures :
  1. Progression Free Survival in Patients Treated With Trisenox® [ Time Frame: 28 days ]
    Progression-Free survival is the period from start of treatment until disease progression, death, or date of last contact.

  2. Overall Survival [ Time Frame: 5 years ]
  3. Associations Between Markers of Angiogenesis (e.g. VEGF) With Response [ Time Frame: 4 years ]
    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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. ≥18 years of age with histologically confirmed metastatic or recurrent endometrial cancer
  2. Documented progression of their endometrial cancer (i.e., within the last 3 months)
  3. If of childbearing potential they must agree to use approved barrier methods of contraception
  4. Presence of at least one measurable lesion that:

    • Can be accurately measured in at least one dimension with longest diameter ≥20 mm using conventional techniques or ≥10 mm with spiral CT scan (or otherwise at least twice the reconstruction interval for CT or MRI scans).
    • Previously irradiated lesions may be considered to be measurable provided: 1) there has been documented progression of the lesion(s) since completion of radiotherapy, and 2) the criteria for measurability as outlined above are met.
  5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  6. Minimum life expectancy of 3 months
  7. Adequate renal and hepatic function (per study protocol guidelines)
  8. Adequate bone marrow function (per study protocol guidelines)
  9. Serum cholesterol <350 mg/dL and triglycerides < 400 mg/dL
  10. Able to understand and give written informed consent
  11. Ejection fraction >55% with no focal left ventricular wall motion abnormalities in patients with a history of coronary artery disease or a history of congestive heart failure.

Exclusion Criteria:

  1. Women who are pregnant or lactating
  2. Presence of brain metastases
  3. Two or more prior cycles of cytotoxic chemotherapy since recurrence (Two total regimens are allowed if one includes adjuvant therapy.)
  4. Prior therapy with Trisenox or known sensitivity to this agent
  5. Prior anticancer treatment (chemotherapy, radiotherapy, immunotherapy, biological response modifiers, signal transduction inhibitors, etc) within 4 weeks prior to the first dose of Trisenox.
  6. Ongoing toxicity associated with prior anticancer therapy (except peripheral neuropathy of ≤ grade 1 by NCI toxicity criteria)
  7. Another primary malignancy within the past three years (except for non-melanoma skin cancer and cervical carcinoma in situ)
  8. Significant uncontrolled cardiovascular disease
  9. Active infection requiring systemic therapy
  10. Known HIV infection
  11. Treatment with any investigational agent within 4 weeks prior to the first dose of Trisenox
  12. Concurrent treatment with immunosuppressive agents other than prescribed corticosteroids
  13. Inadequate recovery from any prior surgical procedure or having undergone any major surgical procedure within 2 weeks prior to the first dose of Trisenox
  14. Patients having undergone recent placement of a central venous access port will be considered eligible if they have recovered
  15. Presence of any other life-threatening illness or organ system dysfunction which, in the opinion of the Investigator, would either compromise the patient's safety or interfere with evaluating the safety of the study drug
  16. Prolonged absolute corrected QT interval (QTc) interval > 500 msec
  17. Underlying conduction disease that prevents measurement of QT interval
  18. History of ventricular tachycardia or any cardiac arrhythmia requiring the placement of an automated intraventricular cardiac defibrillator.
  19. Inability to discontinue therapy with class I or class III antiarrhythmic medications.
  20. Inability to discontinue drugs known to be associated with a risk for torsades de pointes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01184053

United States, North Carolina
North Carolina Cancer Hosptial, UNC
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Principal Investigator: Paola Gehrig, MD UNC Lineberger Comprehensive Cancer Center

Additional Information:
Responsible Party: UNC Lineberger Comprehensive Cancer Center Identifier: NCT01184053     History of Changes
Other Study ID Numbers: LCCC 0920
First Posted: August 18, 2010    Key Record Dates
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
arsenic trioxide
Phase II
vascular endothelial growth factor
University of North Carolina at Chapel Hill

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Arsenic trioxide
Antineoplastic Agents