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 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT00002734
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the ovary or papillary serous carcinoma of extraovarian origin
* Recurrent or persistent following standard surgery and 1 or 2 chemotherapy regimens (with or without paclitaxel), i.e.: persistent disease or progression after chemotherapy with nodules less than the equivalent of 5 x 5 x 5 cm Recurrent carcinoma (after primary or secondary chemotherapy) detected clinically either by exam or rising CA 125 and with radiographic evidence of disease no greater than the equivalent of 5 x 5 x 5 cm nodules
* Residual disease less than 5 x 5 x 5 cm following reassessment laparotomy
* Microscopic residual disease on reassessment laparotomy after chemotherapy
* Tumor TAG-72 positive by immunoperoxidase staining of original or current tumor blocks
* At least 85% free flow of fluid in peritoneal cavity demonstrated by technetium-99m scan or other imaging within 2 weeks prior to treatment
* No evidence of disease outside the peritoneal cavity other than retroperitoneal lymphadenopathy
* No massive ascites
PATIENT CHARACTERISTICS:
* Age: 18 and over
* Performance status: ECOG 0-2
* WBC at least 3,500/mm3
* Platelet count at least 125,000/mm3
* Hemoglobin greater than 9 g/dL
* No nucleated RBC or significant teardrop RBC morphology
* Bilirubin less than 1.5 mg/dL
* AST/ALT less than 4 times normal
* Creatinine less than 2.0 mg/dL
* HIV negative
* Hepatitis B surface antigen negative
* No hypersensitivity to paclitaxel, polyoxethylated castor oil, or topotecan
* No other malignancy in past 5 years except basal cell skin carcinoma
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
* At least 3 weeks since prior biologic therapy and recovered
* No prior monoclonal antibody therapy
* No concurrent immunotherapy
* No prior bone marrow or stem cell transplantation
* At least 3 weeks since prior chemotherapy (6 weeks since nitrosoureas or mitomycin) and recovered
* No concurrent chemotherapy
* At least 3 weeks since prior radiotherapy and recovered
* No prior radiotherapy to the abdominal cavity
* No concurrent radiotherapy
* At least 3 weeks since prior major surgery and recovered
* No prior intraperitoneal therapy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00002734
Study Brief:
Protocol Section:
NCT00002734