Auranofin in Treating Patients With Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
A Pilot Trial to Evaluate the Feasibility Auranofin (Ridaura®) for Asymptomatic Patients With First-Recurrence Epithelial Ovarian Cancer
2 other identifiers
interventional
10
1 country
1
Brief Summary
This pilot clinical trial studies auranofin in treating patients with epithelial ovarian, primary peritoneal, or fallopian tube cancer. Immunosuppressive therapy, such as auranofin, may be an effective treatment for epithelial ovarian, primary peritoneal, or fallopian tube cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started Nov 2012
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 2, 2012
CompletedFirst Submitted
Initial submission to the registry
November 16, 2012
CompletedFirst Posted
Study publicly available on registry
December 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 6, 2015
CompletedAugust 2, 2019
October 1, 2018
1.2 years
November 16, 2012
July 31, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Feasibility of conducting a 10-patient pilot study in asymptomatic ovarian cancer patients using CA 125 elevation
To demonstrate the feasibility of conducting a 10-patient pilot study in asymptomatic ovarian cancer patients with CA 125 elevation. This study could potentially serve as a paradigm to investigate agents that might eventually be used as maintenance therapy in patients at high risk for recurrent disease.
Up to 2 years
Secondary Outcomes (3)
Immunohistochemical staining for PKCt expression in resected tumor samples with Auranofin
up to 2 years
Patients' perceptions of learning of CA 125 elevation
up to 2 years
Oral gold therapy influence on the CA 125 levels
2 years
Study Arms (1)
Treatment (auranofin)
EXPERIMENTALPatients receive auranofin PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions
Eligibility Criteria
You may qualify if:
- Histological or cytological confirmation of epithelial ovarian, primary peritoneal, or fallopian cancer from any previous time point
- Completion of initial therapy of epithelial ovarian, primary peritoneal, or fallopian cancer from any previous time point (includes completion of surgery and/or followed by post-operative chemotherapy including maintenance) with no subsequent treatment for progressive disease
- An increase in serum CA 125 level, as defined as follows: 1) normalization of the CA 125 during first-line chemotherapy followed by an increase of \>= 100 units/mL; OR 2) normalization of the CA 125 during first-line chemotherapy followed by a doubling of the CA 125 beyond the upper limit of normal with a confirmatory measurement within a period of 4 weeks or less that shows the same or higher CA 125 level
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
- Absolute neutrophil count (ANC) \>= 1500
- Platelets (PLT) \>= 100,000
- Hemoglobin (HgB) \> 9.0 g/dL
- Bilirubin \< 1.5 x upper limit of normal (ULN)
- Creatinine within institutional normal limits
- Negative urine pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only
- Willingness to be interviewed by telephone about CA 125 elevation
- Able to provide informed written consent
- Willing to provide tissue blocks for correlative research purposes (please note that if tissue blocks are unavailable, the patient will still be eligible provided they meet all other eligibility criteria)
You may not qualify if:
- Co-morbid systemic illnesses or other severe concurrent disease, which in the judgment of the treating oncologist, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Symptoms (other than anxiety, depression, or other psychological symptoms) that, in the opinion, of the treating oncologist are a direct result of cancer recurrence; (examples of symptoms that would preclude enrollment include unintentional weight loss and new abdominal pain)
- Receiving any other prescribed therapy treatment for ovarian cancer
- Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
- Pregnant women
- Nursing women
- Women of childbearing potential who are unwilling to employ adequate contraception
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Publications (1)
Rousselle B, Massot A, Privat M, Dondaine L, Trommenschlager A, Bouyer F, Bayardon J, Ghiringhelli F, Bettaieb A, Goze C, Paul C, Malacea-Kabbara R, Bodio E. Conception and Evaluation of Fluorescent Phosphine-Gold Complexes: From Synthesis to in vivo Investigations. ChemMedChem. 2022 Jun 3;17(11):e202100773. doi: 10.1002/cmdc.202100773. Epub 2022 Mar 29.
PMID: 35254001DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Aminah Jatoi, M.D.
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2012
First Posted
December 12, 2012
Study Start
November 2, 2012
Primary Completion
January 10, 2014
Study Completion
April 6, 2015
Last Updated
August 2, 2019
Record last verified: 2018-10