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 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT00189566
Eligibility Criteria:
Inclusion Criteria:
* Patients aged \> 18
* Histologically proven diagnosis of cancer of the ovary, the fallopian tube or peritoneum
* Peritoneal and/or nodes and/or visceral metastases
* Disease in progression under treatment or within 6 months after a first or second platinum-based line
* A period of 3 weeks between last chemotherapy and inclusion
* Measurable disease (Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria) or cancer antigen (CA) 125 assessable disease (Gynecologic Cancer Intergroup \[GCIG\] criteria)
* ECOG performance status \< 2
* Life expectancy of at least 12 weeks
Exclusion Criteria:
* Previously received weekly administration of paclitaxel chemotherapy
* Involved in a trial within the last 30 days
* Previously received a bone marrow autogreffe or irradiation of the abdomen within 5 years, due to intensive chemotherapy
* Prior diagnosis of malignancy
* History of ischemic cardiopathy, congestive heart failure (New York Heart Association \[NYHA\] \> 2), arrhythmia, hypertension, or significant valvulopathy
* Pre-existing motor or sensory neurologic pathology or symptoms National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) grade \> 2
* Bone marrow, renal, or hepatic insufficiency
* Severe active infection or occlusive or sub-occlusive disease
* History of symptomatic brain metastases
* Fertile women not using adequate contraceptive methods
* Pregnant or breast feeding women
* Hypersensitivity to compounds chemically related to paclitaxel, topotecan, or carboplatin
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00189566
Study Brief:
Protocol Section:
NCT00189566