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 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
NCT ID:
NCT00072566
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed recurrent or metastatic ovarian epithelial or primary peritoneal cancer
* Unidimensionally measurable disease
* Previously irradiated indicator lesions must have progressed after radiotherapy
* Received a platinum-containing regimen for primary disease
* No more than 2 prior chemotherapy regimens for recurrent disease
* Must have received prior platinum-based chemotherapy for recurrent disease if it has been \> 12 months since treatment for primary disease (except if hypersensitivity to platinum has developed)
* Rechallenge with the same platinum-based regimen is considered 1 prior regimen
* No history or clinical evidence of CNS disease, including primary brain tumor
* No brain metastases
* Performance status - SWOG 0-2
* At least 3 months
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* No bleeding diathesis
* No coagulopathy
* Bilirubin no greater than 1.5 times normal
* ALT or AST no greater than 3 times upper limit of normal
* INR less than 1.5 (for patients receiving warfarin)
* Creatinine no greater than 1.5 times normal
* No proteinuria (less than 1+)
* Proteinuria less than 500 mg/24-hour urine collection
* No prior deep vein thrombosis
* No prior stroke
* No clinically significant cardiovascular disease
* None of the following within the past year:
* Uncontrolled hypertension
* New York Heart Association class II-IV congestive heart failure
* Serious cardiac arrhythmia requiring medication
* Grade II or greater peripheral vascular disease
* None of the following within the past 6 months:
* Unstable angina
* Myocardial infarction
* Transient ischemic attack
* Cerebrovascular accident
* Other arterial thromboembolic event
* No clinically significant peripheral artery disease
* No active infection requiring parenteral antibiotics
* No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No serious, non-healing wound, ulcer, or bone fracture
* No significant traumatic injury within the past 28 days
* No seizures not controlled with standard medical therapy
* No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
* All prior invasive malignancies must be in complete remission
* No other concurrent medical, psychological, or social condition that would preclude study participation
* No prior antiangiogenesis agents
* See Disease Characteristics
* Recovered from prior chemotherapy
* See Disease Characteristics
* Recovered from prior radiotherapy
* More than 28 days since prior major surgical procedure or open biopsy and recovered
* At least 3 weeks since prior therapy directed at the malignancy
* No recent or concurrent full-dose anticoagulants or thrombolytic agents
* Anticoagulants to maintain patency of preexisting, permanent indwelling IV catheters allowed
* No concurrent chronic daily aspirin (greater than 325 mg/day) or nonsteroidal anti-inflammatory drugs known to inhibit platelet function
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00072566
Study Brief:
Protocol Section:
NCT00072566