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

NCT ID: NCT01747798

Last Updated: 2019-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-02
• Study Completion Date: 2015-04-06

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.

Detailed 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.

Conditions

Recurrent Fallopian Tube Cancer; Recurrent Ovarian Epithelial Cancer; Recurrent Primary Peritoneal Cavity Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (auranofin)

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

Group Type: EXPERIMENTAL

auranofin

Intervention Type: DRUG

Given PO

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

auranofin

Given PO

Intervention Type: DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

Ridaura

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aminah Jatoi, M.D.

Role: STUDY_CHAIR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35254001 (View on PubMed)

Other Identifiers

NCI-2012-02207

Identifier Type: REGISTRY

Identifier Source: secondary_id

MC1162

Identifier Type: -

Identifier Source: org_study_id