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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01747798
First received: November 16, 2012
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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 Intervention
Recurrent Fallopian Tube Cancer
Recurrent Ovarian Epithelial Cancer
Recurrent Primary Peritoneal Cavity Cancer
Drug: auranofin
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Feasibility of conducting a 10-patient pilot study in asymptomatic ovarian cancer patients using CA 125 elevation [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    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:
  • Immunohistochemical staining for PKCt expression in resected tumor samples with Auranofin [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    To explore whether immunohistochemical staining for PKCt expression in resected tumor samples appears to be associated with clinical outcomes with Auranofin.

  • Patients' perceptions of learning of CA 125 elevation [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • Oral gold therapy influence on the CA 125 levels [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 10
Study Start Date: November 2012
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747798

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

No publications provided

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT01747798     History of Changes
Other Study ID Numbers: MC1162, NCI-2012-02207
Study First Received: November 16, 2012
Last Updated: April 28, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Ovarian Diseases
Endocrine System Diseases
Gonadal Disorders
Auranofin
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2014