Trial Outcomes & Findings for Trisenox® in Women With Metastatic Endometrial Cancer (NCT NCT01184053)
NCT ID: NCT01184053
Last Updated: 2017-06-14
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
28 days
Results posted on
2017-06-14
Participant Flow
Women 18 years of age with histologically confirmed metastatic or recurrent endometrial cancer at the Lineberger Comprehensive Cancer Center
Participant milestones
| Measure |
Trisenox Treatment
Arsenic trioxide: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Trisenox Treatment
Arsenic trioxide: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
|
|---|---|
|
Overall Study
progression while on treatment
|
3
|
Baseline Characteristics
Trisenox® in Women With Metastatic Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Trisenox Treatment
n=3 Participants
Arsenic trioxide: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 28 daysTo 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.
Outcome measures
| Measure |
Trisenox Treatment
n=3 Participants
Arsenic trioxide: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
|
|---|---|
|
Objective Response (CR+PR) Rate of Subjects Given Trisenox
|
0 Participants
|
SECONDARY outcome
Timeframe: 28 daysProgression-Free survival is the period from start of treatment until disease progression, death, or date of last contact.
Outcome measures
| Measure |
Trisenox Treatment
n=3 Participants
Arsenic trioxide: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
|
|---|---|
|
Progression Free Survival in Patients Treated With Trisenox®
|
0 Participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: All patients who received treatment
Outcome measures
| Measure |
Trisenox Treatment
n=3 Participants
Arsenic trioxide: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
|
|---|---|
|
Overall Survival
|
320 days
Interval 59.0 to
The upper limit of the 95% Confidence Interval was calculated as infinity (and thus NA) due to few events at the time of analysis.
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: No patients achieved a CR or PR response, no angiogenesis was performed.
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.
Outcome measures
Outcome data not reported
Adverse Events
Trisenox Treatment
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Trisenox Treatment
n=3 participants at risk
Arsenic trioxide: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
|
|---|---|
|
Metabolism and nutrition disorders
Rapid weight gain
|
33.3%
1/3 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Number of events 1
|
Other adverse events
| Measure |
Trisenox Treatment
n=3 participants at risk
Arsenic trioxide: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
|
|---|---|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
33.3%
1/3 • Number of events 1
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
33.3%
1/3 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1
|
|
Investigations
Creatinine
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Edema: limb
|
33.3%
1/3 • Number of events 2
|
|
General disorders
Edema: trunk/genital
|
33.3%
1/3 • Number of events 2
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
33.3%
1/3 • Number of events 2
|
|
Vascular disorders
Flushing
|
33.3%
1/3 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
2/3 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
66.7%
2/3 • Number of events 2
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
33.3%
1/3 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
33.3%
1/3 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
33.3%
1/3 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
33.3%
1/3 • Number of events 1
|
|
Nervous system disorders
Pain - Head/headache
|
33.3%
1/3 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Throat/pharynx/larynx
|
66.7%
2/3 • Number of events 2
|
|
Cardiac disorders
Palpitations
|
33.3%
1/3 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
33.3%
1/3 • Number of events 1
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
33.3%
1/3 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
33.3%
1/3 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Specify, __)
|
33.3%
1/3 • Number of events 1
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
33.3%
1/3 • Number of events 1
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Sinus tachycardia
|
33.3%
1/3 • Number of events 2
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
33.3%
1/3 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
33.3%
1/3 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • Number of events 2
|
Additional Information
Robin V. Johnson
UNC Lineberger Comprehensive Cancer Center
Phone: 919-966-1125
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place