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


N/A
18 Years
N/A
Open (Enrolling)
Female
Recurrent Fallopian Tube Cancer, Recurrent Ovarian Epithelial Cancer, Recurrent Primary Peritoneal Cavity Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility of conducting a 10-patient pilot study in asymptomatic ovarian cancer patients using CA 125 elevation

Outcome Description:

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.

Outcome Time Frame:

Up to 2 years

Safety Issue:

No

Principal Investigator

Aminah Jatoi, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

MC1162

NCT ID:

NCT01747798

Start Date:

November 2012

Completion Date:

Related Keywords:

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

Name

Location

Mayo ClinicRochester, Minnesota  55905