Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:41 AM
Ignite Modification Date:
2025-12-25 @ 3:41 AM
NCT ID:
NCT01322802
Eligibility Criteria:
Inclusion Criteria:
* Patients with advanced stage (III/IV) or recurrent ovarian cancer who have been treated to complete remission with standard therapies including primary debulking surgery
* Cancer antigen 125 (CA-125) level within normal limits for the testing laboratory must be documented 90 days prior to enrollment when the assessment of CA-125 is applicable
* Patients must be at least 28 days post cytotoxic chemotherapy, and/or monoclonal antibody therapy, prior to enrollment
* Patients must be at least 28 days post systemic steroids prior to enrollment
* Patients must have Eastern Cooperative Oncology Group (ECOG) Performance Status Score of =\< 2
* Patients must have recovered from major infections and/or surgical procedures, and in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment
* Estimated life expectancy of more than 6 months
* White Blood Cell (WBC) \>= 3000/mm\^3
* Hemoglobin (Hgb) \>= 10 mg/dl
* Hematocrit (Hct) \>= 28%
* Serum creatinine =\< 2.0 mg/dl or creatinine clearance \> 60 ml/min
* Total bilirubin =\< 2.5 mg/dl
* Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) =\< 3 times upper limit of normal (ULN)
* Blood glucose \< 1.5 ULN
Exclusion Criteria:
* Patients with any of the following cardiac conditions: symptomatic restrictive cardiomyopathy; unstable angina within 4 months prior to enrollment; New York Heart Association functional class III-IV heart failure on active treatment; symptomatic pericardial effusion
* Uncontrolled diabetes
* Patients with any contraindication to receiving sargramostim (rhuGM-CSF) based products
* Ovarian cancer of a low malignant potential phenotype or clear cell histology
* Patients with any clinically significant autoimmune disease uncontrolled with treatment
* Patients who are currently receiving an anti-IGF-IR monoclonal antibody as part of their treatment regimen
* Patients who are simultaneously enrolled in any other treatment study
* All subjects able to bear children
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01322802
Study Brief:
Protocol Section:
NCT01322802