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 @ 2:35 PM
Ignite Modification Date:
2025-12-24 @ 2:35 PM
NCT ID:
NCT00183859
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed recurrent, metastatic, or residual cancer with disease confined mostly to the peritoneal cavity. Patients with asymptomatic extra-peritoneal disease are eligible.
* Measurable or evaluable disease. Patients with malignant ascites or carcinomatosis only (documented by cytology or during surgery) are eligible. Patients with ovarian cancer and disease manifested only by an elevated CA-125 are also eligible.
* Adequate hepatic, renal, and bone marrow functions: bilirubin less than or equal to 2.0 mg/dl; creatinine less than or equal to 2.0 mg/dl, alkaline phosphatase less than or equal to 3 x upper limit of normal (uln), AST or ALT less than or equal to 3 x uln; AGC greater than or equal to 1500, platelets greater than or equal to 100,000.
* SWOG performance status 0-2
* Fully recovered from acute toxicities from prior surgery, chemotherapy, or radiation therapy.
* Patients must use an approved method of birth control.
Exclusion Criteria:
* Medical, social, or psychological factors which could prevent patient from receiving treatment.
* Prior therapy with intra-peritoneal irinotecan
* Significant intra-peritoneal adhesions detected clinically or by prior surgical exploration
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00183859
Study Brief:
Protocol Section:
NCT00183859