Auranofin in Treating Patients With Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Recurrent Ovarian Epithelial Cancer Clinical Trial

Official title:

A Pilot Trial to Evaluate the Feasibility Auranofin (Ridaura®) for Asymptomatic Patients With First-Recurrence Epithelial Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01747798
• Other study ID #: MC1162
• Secondary ID: NCI-2012-02207
• Status: Completed
• Phase: Early Phase 1
• Start date: November 2, 2012
• Est. completion date: April 6, 2015

Study information

• Verified date: October 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

PRIMARY OBJECTIVES:

I. To demonstrate the feasibility of conducting a 10-patient pilot study in asymptomatic ovarian cancer patients with cancer antigen (CA 125) elevation.

SECONDARY OBJECTIVES:

I. To explore whether oral gold therapy either stabilizes or lowers the CA 125 level and maintains patients in an asymptomatic state and to provide descriptive data on tumor response and duration of response.

II. To acquire qualitative data on patients' perceptions of learning of CA 125 elevation.

III. To explore whether immunohistochemical staining for PKC iota expression in resected tumor samples appears to be associated with clinical outcomes with auranofin.

OUTLINE:

Patients receive auranofin orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 2 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 6, 2015
• Est. primary completion date: January 10, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Fallopian Tube Neoplasms
• Recurrent Fallopian Tube Cancer
• Recurrent Ovarian Epithelial Cancer
• Recurrent Primary Peritoneal Cavity Cancer

Intervention

Drug:
• auranofin
Given PO

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Immunohistochemical staining for PKCt expression in resected tumor samples with Auranofin	To explore whether immunohistochemical staining for PKCt expression in resected tumor samples appears to be associated with clinical outcomes with Auranofin.	up to 2 years
Secondary	Patients' perceptions of learning of CA 125 elevation		up to 2 years
Secondary	Oral gold therapy influence on the CA 125 levels	To explore whether oral gold therapy either stabilizes or lowers the CA 125 level and maintains patients in an asymptomatic state and to provide descriptive data on tumor response and duration of response.	2 years