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 @ 4:23 AM
Ignite Modification Date:
2025-12-25 @ 4:23 AM
NCT ID:
NCT00127920
Eligibility Criteria:
Inclusion Criteria:
* Subjects with a histologic or cytologic diagnosis of stage III/IV ovarian cancer, fallopian tube epithelial cancer, or peritoneal cancer who have not received prior chemotherapy or radiotherapy.
* Subjects must have the appropriate surgery for their gynecologic cancer. However, subjects may be treated in a neoadjuvant manner, with surgery being performed after chemotherapy cycles 1, 2, or 3.
* If neoadjuvant therapy is not administered, subjects must receive their first dose no more than six weeks postoperatively.
* Subjects must have adequate bone marrow, renal and hepatic function as defined by WBC \> 3,000 cells/cu ml., platelets \> 100,000/cu.ml., calculated creatinine clearance \> 50 ccs/min., bilirubin \< 1.5 mg/dl, and SGOT \< three times normal.
* Karnofsky performance status \> 50%.
* Subjects who have signed an institutional review board (IRB) approved informed consent form.
Exclusion Criteria:
* Subjects with epithelial ovarian cancer of low malignancy potential.
* Subjects with septicemia, severe infection, or acute hepatitis.
* Subjects with severe gastrointestinal bleeding.
* Subjects with a history of congestive heart failure, angina, or a history of myocardial infarction within the past six months.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00127920
Study Brief:
Protocol Section:
NCT00127920