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 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT00025233
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed persistent or recurrent squamous cell carcinoma (SCC) of the cervix
* Patients must have received at least 1, but no more than 2, prior cytotoxic chemotherapy regimens for advanced, metastatic, or recurrent SCC of the cervix
* Chemotherapy administered as a radio-sensitizer does not count as 1 regimen
* Documented disease progression
* At least 1 unidimensionally measurable lesion\*
* At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
* No tumor involving major blood vessels
* No history or physical evidence of CNS disease, including primary or metastatic brain tumor
* Ineligible for a higher priority Gynecological Oncology Group (GOG) protocol (if one exists), including any active GOG phase III protocol for the same patient population
* Performance status - GOG 0-2 (if received 1 prior regimen)
* Performance status - GOG 0-1 (if received 2 prior regimens)
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* No known bleeding disorder or coagulopathy
* No other active bleeding or pathologic condition that would confer a high risk of bleeding
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* SGOT ≤ 2.5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN
* INR ≤ 1.5 (or 2-3 for patients on a stable dose of therapeutic warfarin or low molecular weight heparin)
* PTT \< 1.2 times control
* Creatinine ≤ 1.5 times ULN
* Creatinine clearance \> 60 mL/min
* No proteinuria
* Urine protein \< 1+ on dipstick or \< 30 mg/dL
* Urine protein \< 1000 mg by 24-hour urine collection
* No clinically significant cardiovascular disease
* No uncontrolled hypertension
* No myocardial infarction or unstable angina within the past 6 months
* No New York Heart Association grade II-IV congestive heart failure
* No serious cardiac arrhythmia requiring medication
* No grade II or greater peripheral vascular disease
* No history of stroke within the past 5 years
* No greater than grade 1 sensory or motor neuropathy
* No active infection requiring parenteral antibiotics
* No serious nonhealing wound, ulcer, or bone fracture
* No history or physical evidence of seizures not controlled with standard medical therapy
* No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
* No other invasive malignancy within the past 5 years except nonmelanomatous skin cancer
* No significant traumatic injury within the past 4 weeks
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 3 months after completion of study treatment
* No prior bevacizumab
* At least 3 weeks since prior immunologic agents for SCC of the cervix
* See Disease Characteristics
* Recovered from prior chemotherapy
* No prior non-cytotoxic chemotherapy for persistent or recurrent disease
* At least 1 week since prior hormonal therapy for SCC of the cervix
* Concurrent hormone replacement therapy allowed
* See Disease Characteristics
* Recovered from prior radiotherapy
* Recovered from recent prior surgery
* At least 4 weeks since prior major surgical procedure or open biopsy
* At least 1 week since prior placement of vascular access device or core biopsy
* No concurrent major surgical procedure
* At least 3 weeks since other prior therapy for SCC of the cervix
* No prior anticancer therapy that would preclude study therapy
* No concurrent anticoagulants other than those required to maintain the patency of indwelling IV catheters
* No concurrent chronic daily aspirin greater than 325 mg/day or other nonsteroidal anti-inflammatory medications that are known to inhibit platelet function at doses used for chronic inflammatory diseases
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00025233
Study Brief:
Protocol Section:
NCT00025233