EUCTR2005-003209-10-FI进行中（未招募）不适用
VEGF, VEGFR1 and VEGFR2 expression in serous epithelial ovarian carcinoma, and its association to the efficacy of bevacizumab combined with paclitaxel and carboplatin as first line treatment
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Histologically confirmed diagnosis of FIGO St III-IV serous epithelial ovarian carcinoma.
- •2. Age 18- 75 years
- •3. Measurable disease by RECIST criteria or evaluable disease by Ca-125 criteria.
- •4. ECOG performance status 0-2
- •5. Lab values in protocol
- •6.Women of childbearing potential must have a negative serum pregnancy test done 1 week prior to the administration of the study drug. She and her partner should prevent pregnancy (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) up to at least 6 months after last treatment completion or the last drug dose, whatever happens first
- •7.Signed written informed consent according to ICH/GCP and the local regulations (approved by the Independent Ethics Committee [IEC]) will be obtained prior to any study specific screening procedures
- •8.Patient must be able to comply with the protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 0 (Patients must have recovered from any major surgery), or anticipation of need for major surgical procedure during the course of the study
- •2. Ongoing anti-neoplastic chemo- or radiotherapy (minimum 4 weeks interval before study inclusion)
- •3. Previous malignant disease except for cured carcinoma in situ of the cervix or basalioma of skin
- •4. Borderline tumors
- •5. Planned radiotherapy for underlying disease
- •6. Clinical or radiological evidence of CNS metastases
- •7. Serious non-healing wound or ulcer
- •8. Bleeding diathesis or coagulopathy
- •9. Previous or concurrent thromboembolic disease
- •10. Uncontrolled hypertension
- •11. Clinically significant active cardiovascular disease for example cerebrovascular accidents (= 6 months), myocardial infarction (= 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication
- •12. Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complications
- •13. Ongoing treatment with acetylsalicylic acid (> 325 mg/day) or other medications known to predispose to gastrointestinal ulceration (e.g. chronic use of non-steroidal anti-inflammatory analgesics)
- •14. Pregnancy (positive serum pregnancy test) and lactation
- •15. Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial
研究者
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