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Endometrial CarcinomaPhase 2NRRNCT01184053

Trisenox® in Women With Metastatic Endometrial Cancer

A Phase 2 study testing Arsenic trioxide in people with Endometrial Carcinoma, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Carcinoma
What is being tested?
Arsenic trioxide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
Mar 2010to Mar 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥18 years of age with histologically confirmed metastatic or recurrent endometrial cancer
  • Documented progression of their endometrial cancer (i.e., within the last 3 months)
  • If of childbearing potential they must agree to use approved barrier methods of contraception
  • 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.
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  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Minimum life expectancy of 3 months
  • Adequate renal and hepatic function (per study protocol guidelines)
  • Adequate bone marrow function (per study protocol guidelines)
  • Serum cholesterol <350 mg/dL and triglycerides < 400 mg/dL
  • Able to understand and give written informed consent
  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • North Carolina Cancer Hosptial, UNC

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Official title: A Phase II Trial of Trisenox in Women With Recurrent or Metastatic Endometrial Adenocarcinoma

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.

Read the 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.

Being tested
Arsenic trioxide
Keywords
endometrial, carcinoma, recurrent, metastatic, Trisenox, arsenic trioxide, Phase II, VEGF, gynecology, Lineberger, UNC, vascular endothelial growth factor, University of North Carolina at Chapel Hill
Medical subject headings
Endometrial Neoplasms, Carcinoma, Recurrence, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arsenic trioxideDrug

    Also called Trisenox

    Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.

Study groups in NCT01184053
Study groupRoleWhat they receive
Trisenox treatmentExperimentalArsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
Receives: Drug: Arsenic trioxide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 28 days

Secondary outcomes (3)

  1. Progression Free Survival in Patients Treated With Trisenox®

    Progression-Free survival is the period from start of treatment until disease progression, death, or date of last contact.

    Measured: 28 days

  2. Overall Survival

    Measured: 5 years

  3. Associations Between Markers of Angiogenesis (e.g. VEGF) With Response

    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.

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionMar 2012
  4. Study completionMar 2012

Why it stopped: Accrual was very low. No subject had been enrolled in a year.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01184053
Sponsor's protocol ID
LCCC 0920
Acronym
NRR
Status last verified
May 2017
First submitted
22 Jul 2010
Last updated
14 Jun 2017
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Arsenic trioxide in people with Endometrial Carcinoma, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response (CR+PR) Rate of Subjects Given Trisenox (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01184053.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.

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