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

• ClinicalTrials.gov Identifier: NCT01747798
• Recruitment Status: Completed
• First Posted: December 12, 2012
• Last Update Posted: August 2, 2019
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): Mayo Clinic

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Recurrent Fallopian Tube Cancer; Recurrent Ovarian Epithelial Cancer; Recurrent Primary Peritoneal Cavity Cancer	Drug: auranofin; Other: laboratory biomarker analysis	Early Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Trial to Evaluate the Feasibility Auranofin (Ridaura®) for Asymptomatic Patients With First-Recurrence Epithelial Ovarian Cancer
• Actual Study Start Date: November 2, 2012
• Actual Primary Completion Date: January 10, 2014
• Actual Study Completion Date: April 6, 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: auranofin; Given PO; Other Name: Ridaura; Other: laboratory biomarker analysis; Correlative studies

Outcome Measures

Primary Outcome Measures :

1. Feasibility of conducting a 10-patient pilot study in asymptomatic ovarian cancer patients using CA 125 elevation [ Time Frame: Up to 2 years ]
   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.

Secondary Outcome Measures :

1. Immunohistochemical staining for PKCt expression in resected tumor samples with Auranofin [ Time Frame: up to 2 years ]
   To explore whether immunohistochemical staining for PKCt expression in resected tumor samples appears to be associated with clinical outcomes with Auranofin.
2. Patients' perceptions of learning of CA 125 elevation [ Time Frame: up to 2 years ]
3. Oral gold therapy influence on the CA 125 levels [ Time Frame: 2 years ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Investigators

• Study Chair: Aminah Jatoi, M.D.; Mayo Clinic

More Information

• Responsible Party: Mayo Clinic
• ClinicalTrials.gov Identifier: NCT01747798
• Other Study ID Numbers: MC1162; NCI-2012-02207 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
• First Posted: December 12, 2012
• Last Update Posted: August 2, 2019
• Last Verified: October 2018

Additional relevant MeSH terms:

Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Ovarian Neoplasms; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Auranofin; Antirheumatic Agents