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:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT00964756
Eligibility Criteria:
Inclusion Criteria:
* Patients must have histologically documented invasive epithelial ovarian, extraovarian, fallopian tube or endometrial carcinoma.
* Patients must have persistent or recurrent disease after standard debulking/staging surgery and conventional therapy.
* Patients must have evidence of intraabdominal disease; disease may be measurable or nonmeasurable.
* Patients must have a GOG performance status of 0, 1, or 2, and have a life expectancy of greater than 3 months.
* Patients must have adequate hematologic, renal, and hepatic function defined as:
* WBC \> 3,000 ul
* Granulocytes \> 1,500 ul
* Platelets \> 100,000
* Creatinine clearance \> 80 mg/dl or serum creatinine \> 2.0
* Serum transaminases \< 2.5 x upper limits of normal
* Normal serum bilirubin
* PT/PTT/INR \< 1.5 x institutional ULN
* O2 saturation \> or = 92 %
* Patients must be 19 years or older and must have signed informed consent
Exclusion Criteria:
* Patients with epithelial tumors of low malignant potential, stromal tumors and germ cell tumors of the ovary are ineligible to participate in the study.
* Patients with the only site of disease located beyond the abdominal cavity are ineligible to participate in the study.
* Patients who are pregnant or lactating are ineligible to participate in the study.
* Patients with a GOG performance status of 3 or 4 are ineligible to participate in the study.
* Patients with active heart disease (characterized by angina, unstable arrhythmia, congestive heart failure or EF \< 55%, pulmonary hyper- tension, active or chronic debilitating pulmonary disease(i.e., active pneumonia, severe COPD, pulmonary edema, O2 saturation \< 92%), or coagulation disorders (i.e. bleeding disorders, or on therapeutic anti- coagulants)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
19 Years
Study:
NCT00964756
Study Brief:
Protocol Section:
NCT00964756