Trisenox® in Women With Metastatic Endometrial Cancer

NCT01184053 | Terminated Phase 2 Results DMC

• 1 other identifier: LCCC 0920
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Carcinoma

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

Outcome Measures

Primary Outcomes (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.

  28 days

Secondary Outcomes (3)

• Progression Free Survival in Patients Treated With Trisenox®

  28 days

• Overall Survival

  5 years

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

  4 years

Study Arms (1)

Trisenox treatment

EXPERIMENTAL

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

Drug: Arsenic trioxide

Interventions

Arsenic trioxide DRUG

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

Also known as: Trisenox

Trisenox treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.
• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Cephalon: collaborator

Study Sites (1)

North Carolina Cancer Hosptial, UNC

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• web address for Lineberger Comprehensive Cancer Center, UNC
• web address for the National Cancer Institute (NCI)

MeSH Terms

Conditions

Endometrial Neoplasms; Carcinoma; Recurrence; Neoplasm Metastasis

Interventions

Arsenic Trioxide

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes

Intervention Hierarchy (Ancestors)

Arsenicals; Inorganic Chemicals; Oxides; Oxygen Compounds

Limitations and Caveats

The study accrued few patients secondary to the strict entry criteria regarding labs, EKG, etc in a sick endometrial cancer population.

Results Point of Contact

• Title: Robin V. Johnson
• Organization: UNC Lineberger Comprehensive Cancer Center

Robin_V_Johnson@med.unc.edu

919-966-1125

Study Officials

• Paola Gehrig, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2010
• First Posted: August 18, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: June 14, 2017
• Results First Posted: June 14, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)