Auranofin in Treating Patients With Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer - Full Text View

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:

Genetics Home Reference related topics: ovarian cancer

MedlinePlus related topics: Cancer

Drug Information available for: Auranofin

Genetic and Rare Diseases Information Center resources: Ovarian Cancer Fallopian Tube Cancer Ovarian Epithelial Cancer

U.S. FDA Resources

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 2016 (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 (Adult, Senior)
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


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 18, 2016
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 23, 2016