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 @ 2:33 AM
Ignite Modification Date:
2025-12-25 @ 2:33 AM
NCT ID:
NCT00390234
Eligibility Criteria:
Inclusion Criteria:
* Histologically/cytologically confirmed soft tissue sarcoma of gynecologic tract including 1 of the following subtypes: uterine leiomyosarcoma, malignant mixed mullerian tumor/carcinosarcoma, disease originating in ovary/fallopian tube allowed
* Locally advanced/unresectable/metastatic disease
* Previously treated disease must have radiographic/clinical evidence of PD
* Measurable disease-at least 1 lesion in at least 1 dimension (longest diameter) as \>=20mm with conventional techniques or as \>=10mm with spiral CT scan
* Indicator lesions may not have been previously treated with surgery/radiotherapy/radiofrequency ablation unless PD has been confirmed
* ECOG PS 0-2 OR Karnofsky PS 60-100%
* Life expectancy\>=3 months
* WBC\>=3,000/mm\^3
* Absolute neutrophil count\>=1,500/mm\^3
* Platelet count\>=75,000/mm\^3
* Bilirubin=\<1.5xULN
* AST and ALT=\<3xULN
* INR=\<1.5 (unless on warfarin)
* Creatinine=\<1.5xULN OR creatinine clearance\>=60 mL/min
* Urine protein\<1+ by dipstick OR 24-hour urine protein\<500 mg OR urine protein:creatinine ratio\<1
* Not pregnant/nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for ≥6 months after treatment - No other active malignancy within past 5 years except adequately treated cervical carcinoma in situ/nonmelanoma skin cancer
* No known hypersensitivity to Chinese hamster ovary cell products/other recombinant human antibodies
* No history of allergic reactions attributed to compounds of similar chemical/biological composition to study agents
* No serious/nonhealing wound/ulcer/bone fracture
* No abdominal fistula/gastrointestinal perforation/bowel obstruction/intraabdominal abscess within past 28 days
* No significant traumatic injuries within past 28 days
* No evidence of bleeding diathesis/coagulopathy
* No uncontrolled intercurrent illness including but not limited to: Ongoing/active infection, psychiatric illness or social situations that would preclude study compliance
* \<=2 prior cytotoxic chemotherapy regimen for recurrent, locally advanced or metastatic disease
* Recovered from prior therapy
* No prior antiangiogenic agent
Exclusion Criteria:
* \< 4weeks since prior chemotherapy (\<6 weeks for nitrosoureas/carmustine/mitomycin C), prior investigational treatment, radiotherapy and major surgery/open biopsy
* 1 week since prior core biopsy
* 1 month since prior thrombolytic agents
* Concurrent full-dose anticoagulants with INR\>1.5 allowed if: In-range INR (usually between 2-3) on stable dose of oral anticoagulant or low molecular weight heparin,
* OR; For patients on warfarin, the upper target for INR is ≤3 No active bleeding/pathological condition that carries a high risk of bleeding (e.g. tumor invading major vessels/known varices)
* No evidence of CNS disease including primary brain tumor/brain metastasis
* No other concurrent investigational agents - No concurrent major surgery
* No concurrent combination antiretroviral therapy for HIV-positive patients
* Clinically significant cardiovascular disease including:
* Cerebrovascular accident within past 6 months,
* Uncontrolled hypertension defined as BP\>150/100mmHg OR systolic BP\>180mmHg if diastolic BP\<90 mmHg, on ≥2 repeated determinations on separate days within past 3 months,
* OR; Antihypertensive medications allowed as long as dose and number of antihypertensive medications have not increased within past 2 weeks, Myocardial infarction, coronary artery bypass graft, or unstable angina within past 6 months, OR;
* OR; NYHA class III-IV congestive heart failure, serious cardiac arrhythmia requiring medication, or unstable angina pectoris within past 6 months, Clinically significant peripheral vascular disease within past 6 months
* OR; pulmonary embolism, deep vein thrombosis, or other thromboembolic event within past 6 months
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00390234
Study Brief:
Protocol Section:
NCT00390234