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 @ 1:16 PM
Ignite Modification Date:
2025-12-24 @ 1:16 PM
NCT ID:
NCT00672295
Eligibility Criteria:
Inclusion Criteria:
* Pts must have histologic or cytologic evidence of ovarian, peritoneal, or tubal cancer
* All pts must have measurable disease
* \> 18 yrs
* Expected survival of at least 3 months
* Pts must have GOG performance status pf 0, 1 or 2
* Pts must have adequate:Bone marrow function, renal function, hepatic function, neurologic function
* No chemo, radiotherapy, biologic, hormonal, or investigational drug therapy within 28 days prior to study entry
* Pts may have had up to 3 prior cytotoxic chemo regimens including prior treatment w carboplatin \& paclitaxel
* Capable of providing written informed consent
* Pts of childbearing potential must have negative serum pregnancy test prior to study entry \& be practicing effective method of birth control during course of study, in manner such that risk of failure is minimized. Prior to study enrollment, women of childbearing potential must be advised of importance of avoiding pregnancy during trial participation \& potential risk factors for unintentional pregnancy
* Pts must have tissue block from their tumor available for evaluation for microarray \& immunoblot analyses. Pretreatment tumor tissue may be obtained from either archival tissue or be obtained by guided by guided core needle or simple biopsy it must be performed within four weeks prior to enrollment on study. Pts must have tumor that is accessible to biopsy \& consent to undergo post-treatment biopsy after cycle #2 of treatment as well
Exclusion Criteria:
* Pts w epithelial ovarian tumors of low malignant potential (borderline tumor)
* Pts w history of other invasive malignancies, w exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within last 5 yrs
* Pts who have following cardiac conditions: uncontrolled angina or myocardial infarction within past 6 months; diagnosed or suspected congenital long QT syndrome; Any history of clinically significant ventricular arrhythmias; Prolonged QTc interval on pre-entry electrocardiogram on both Fridericia \& Bazett's correction; uncontrolled hypertension
* History of significant bleeding disorder unrelated to cancer, including: diagnosed congenital bleeding disorders; diagnosed acquired bleeding disorder within 1 yr
* Pts currently taking drugs that are generally accepted to have risk of causing Torsades de Pointes including: quinidine, procainamide, disopyramide; amiodarone, sotalol, ibutilide, dofetilide; erythromycins, clarithromycin; chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide; cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
* Serum creatinine \> 1.5 times institutional upper limits of normal
* Pts taking certain concomitant medications, consider following prohibitions: medications that inhibit platelet function or anticoagulants
* Pts who have received radiation therapy to \> 30 percent of bone marrow
* Pts w history of grade 3 hypersensitivity to paclitaxel or carboplatin
* Pts w septicemia, severe infection, acute hepatitis, other uncontrolled severe medical conditions
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00672295
Study Brief:
Protocol Section:
NCT00672295