Auranofin in Treating Patients With Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Recurrent Fallopian Tube Cancer; Recurrent Ovarian Epithelial Cancer; Recurrent Primary Peritoneal Cavity Cancer
Intervention: auranofin (Drug); laboratory biomarker analysis (Other)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s): Aminah Jatoi, M.D., Study Chair, Affiliation: Mayo Clinic
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.
Clinical Details
Official title: A Pilot Trial to Evaluate the Feasibility Auranofin (Ridaura®) for Asymptomatic Patients With First-Recurrence Epithelial Ovarian Cancer
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Feasibility of conducting a 10-patient pilot study in asymptomatic ovarian cancer patients using CA 125 elevation
Secondary outcome: Immunohistochemical staining for PKCt expression in resected tumor samples with AuranofinPatients' perceptions of learning of CA 125 elevation Oral gold therapy influence on the CA 125 levels
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Mayo Clinic, Rochester, Minnesota 55905, United States
Additional Information
Starting date: November 2012
Last updated: March 24, 2015
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