Trial · NCT01184053
Trisenox® in Women With Metastatic Endometrial Cancer
NCT01184053, Phase 2, Terminated, UNC Lineberger Comprehensive Cancer Center; results first posted 2017-06-14
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Trisenox® in Women With Metastatic Endometrial Cancer. Trials, record NCT01184053. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01184053
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trisenox® in Women With Metastatic Endometrial Cancer
- NCT number
- NCT01184053
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Conditions
- Endometrial Carcinoma
- Interventions
- Arsenic trioxide
- First posted
- 2010-08-18
- Last updated
- 2017-06-14
- Results first posted
- 2017-06-14
- Limitations and caveats
- The study accrued few patients secondary to the strict entry criteria regarding labs, EKG, etc in a sick endometrial cancer population.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response (CR+PR) Rate of Subjects Given Trisenox | 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 | Progression Free Survival in Patients Treated With Trisenox® | 28 days | Progression-Free survival is the period from start of treatment until disease progression, death, or date of last contact. |
| Secondary | Overall Survival | 5 years | |
| Secondary | Associations Between Markers of Angiogenesis (e.g. VEGF) With Response | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response (CR+PR) Rate of Subjects Given Trisenox | 28 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression Free Survival in Patients Treated With Trisenox® | 28 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival | 5 years | All patients who received treatment | days | MEDIAN |
| SECONDARY | Associations Between Markers of Angiogenesis (e.g. VEGF) With Response | 4 years | No patients achieved a CR or PR response, no angiogenesis was performed. |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response (CR+PR) Rate of Subjects Given Trisenox | Trisenox Treatment | 0 | Participants | ||
| Progression Free Survival in Patients Treated With Trisenox® | Trisenox Treatment | 0 | Participants | ||
| Overall Survival | Trisenox Treatment | 320 | 95% Confidence Interval 59 to NA | days |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Trisenox Treatment | 3 | |
| Overall Study | COMPLETED | Trisenox Treatment | 0 | |
| Overall Study | NOT COMPLETED | Trisenox Treatment | 3 |
Source ClinicalTrials.gov
Adverse events32
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | Trisenox Treatment | 1 | 3 | 1 |
| other | Ascites (non-malignant) | Gastrointestinal disorders | Trisenox Treatment | 1 | 3 | 1 |
| other | Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | Trisenox Treatment | 1 | 3 | 1 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Trisenox Treatment | 1 | 3 | 1 |
| other | Creatinine | Investigations | Trisenox Treatment | 1 | 3 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Trisenox Treatment | 1 | 3 | 1 |
| other | Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | Trisenox Treatment | 1 | 3 | 1 |
| other | Edema: limb | General disorders | Trisenox Treatment | 1 | 3 | 2 |
| other | Edema: trunk/genital | General disorders | Trisenox Treatment | 1 | 3 | 2 |
| other | Fatigue (asthenia, lethargy, malaise) | General disorders | Trisenox Treatment | 1 | 3 | 2 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Trisenox Treatment | 2 | 3 |
| Total, other adverse events | Trisenox Treatment | 3 | 3 |
| Total, serious adverse events | Trisenox Treatment | 2 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01184053
GET https://conductscience.org/api/trials/v1/NCT01184053/events?page=2