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 @ 3:29 AM
Ignite Modification Date:
2025-12-25 @ 3:29 AM
NCT ID:
NCT00626405
Eligibility Criteria:
* Histologic confirmed diagnosis of malignant melanoma
* Stage IV disease
* Not amenable tosurgery
* Measurable disease with at least one lesion whose longest diameter canbe measured as ≥ 20 mm by CT or MRI scans OR ≥ 10 mm by spiral CT
* No disease that is measurable by physical examination only
* No brain metastases per MRI or CT
* No radiographically documented invasion of adjacent organs(duodenum, stomach, etc.) or tumor invading major blood vessels
* ECOG performance status 0-1
* Life expectancy ≥ 4 months
* ANC ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 9 g/dL (transfusion allowed)
* Creatinine ≤ 1.5 times upper limit of normal (ULN)
* Total bilirubin ≤ 1.5 mg/dL (unless Gilbert syndrome)
* AST ≤ 2.5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN
* Urine protein:creatinine ratio \< 1.0 at screening ORproteinuria \< 2+ by urine dipstick or protein ≤ 1 g by 24-hour urine collection
* Negative serum pregnancy test
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Active infection requiring parenteral antibiotics
* Poorly controlled high blood pressure (≥ 150 mm Hg systolic and/or100 mm Hg diastolic) despite treatment
* NYHA class II-IV congestive heart failure
* Serious cardiac arrhythmia requiring medication
* Myocardial infarction or unstable angina within the past 6 months
* Clinically significant peripheral vascular disease
* Deep venous thrombosis or pulmonary embolus within the past year
* Active bleeding or pathological conditions that carry high risk of bleeding (e.g., known esophageal varices)
* Serious, non-healing wound (including wounds healing by secondary intention), ulcer or bone fracture
* Abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within the past 6 months
* History of CNS disease (e.g., primary brain tumor, vascular abnormalities, etc.)
* Clinically significant stroke or TIA within the past 6 months
* Seizures not controlled with standardmedical therapy
* Peripheral neuropathy ≥ grade 2
* History of other malignancy within the past 5 years except basal cell or squamous cell carcinoma of the skin treatable with local resection only or carcinoma in situ of the cervix
* Significant traumatic injury within the past 4 weeks
* History of hypertensive crisis or hypertensive encephalopathy
* Active or recent (≤ 30 days) history of hemoptysis (≥ ½ teaspoon of bright red blood per episode)
* Known hypersensitivity to any of the components of bevacizumab
* Known to be HIV positive
* Current or known history of hepatitis
* Prior adjuvant chemotherapy and/or immunotherapy for this cancer allowed
* No prior treatment with agents disrupting VEGF activity (i.e., bevacizumab,VEGF-trap, anti-VEGFR Mab)
* No ongoing need for full-dose oral or parenteral anticoagulation
* No ongoing anti-platelet treatment other than low-dose aspirin(i.e., aspirin 81 mg daily)
* No other investigational agents within the past 4 weeks
* No major surgical procedure or open biopsy within the past 4 weeks
* No fine needle aspirations or core biopsies within the past 7 days
* No prior chemotherapy in the metastatic setting
* No prior treatment with sunitinib malate or sorafenib
* No prior treatment with any taxane-based chemotherapy
* Patients who have had \> 25% of their functional bone marrow irradiated are not eligible for this trial
* No adjuvant radiation therapy within the past 4 weeks
* More than 2 weeks since prior and no concurrent palliative radiation therapy
* No concurrent major surgical procedure
* No concurrent participation in another clinical study for procedures or agents that treat the same primary study malignancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00626405
Study Brief:
Protocol Section:
NCT00626405