EUCTR2011-003301-16-IT进行中（未招募）不适用
A Randomized Phase II Trial of Carboplatin-Paclitaxel compared to Carboplatin-Paclitaxel-Bevacizumab in advanced (stage III-IV) or recurrent endometrial cancer. - MITO END2
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI0 个研究点目标入组 108 人开始时间: 2011年12月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 108
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. =18 years of age. 2. ECOG Performance Status of 0–2. 3. Life expectancy of at least 12 weeks. 4. Patients must have advanced stage III or IV, or recurrent histologically-confirmed endometrial cancer. 5. Endometrial cancer will include all carcinomas, including endometrioid carcinoma, papillary serous carcinoma, clear cell carcinoma. 6. No previous chemotherapy lines (previous radiotherapy is allowed). 7 Measurable and not measurable disease. 8 Adequate renal and hepatic function, defined as: • Total serum bilirubin = institutional ULN unless patient has Gilbert’s syndrome in which case direct bilirubin must be < ULN for the institution. • AST and/or ALT = 2.5 x ULN for the institution. (or = 5 x ULN if liver metastases are present) • Alkaline phosphatase < 1.5 x ULN for the institution (if > 1.5 x ULN, then alkaline phosphatase liver fraction must be < 1.5 ULN). • Serum creatinine = 1.5 x ULN for the institution (or calculated creatinine clearance = 50 mL/min/1.73 m2) 9 Adequate bone marrow function, defined as: • Total leukocytes ³ 3.0 x 109/L. • ANC ³ 1.5 x 109/L. • Platelet count ³ 100 x 109/L. Able to understand and give written informed consent. 10 Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
- •one previous chemoterapy lines is allowed if platinum free interval is more than six mounths (previous radiotherapy is allowed)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 28
排除标准
- •1. Previous cytotoxic chemotherapy. 2. Women who are pregnant or lactating. 3. Presence of brain or other central nervous system metastases. 4. Anticancer treatment (Hormonal therapy, radiotherapy) within 4 weeks prior to randomization. 5. Ongoing toxicity associated with prior anticancer therapy. 6. Inadequate recovery from any prior surgical procedure or having undergone any major surgical procedure within 4 weeks prior to randomization. Patients who have recovered from placement of a central venous access port within 2 weeks of Cycle 1 Day 1 will be considered eligible. 7. Another primary malignancy within the past five years (except for non-melanoma skin cancer and cervical carcinoma in situ). 8. Current or recent (within 10 days prior to the first study drug dose) chronic daily treatment with aspirin (>325 mg/day). 9. Current or recent (within 10 days prior to the first study drug dose) use of full-dose oral or parenteral anticoagulant or thrombolytic agent for therapeutic purposes. 10. Inadequate coagulation parameters:activated partial thromboplastin time (APTT) >1.5 xULN or INR >1.5. 11. Known HIV infection. 12. Known hepatitis B or C infection. 13. Concurrent treatment with immunosuppressive or investigational agents. 14. History or evidence of thrombotic or hemorrhagic disorders; including cerebrovascular accident (CVA) / stroke or transient ischemic attack (TIA) or subarachnoid haemorrhage within _6 months prior to the first study treatment). 15. Uncontrolled hypertension (sustained systolic >150 mm Hg and/or diastolic >100 mm Hg despite antihypertensive therapy) or clinically significant (i.e. active) cardiovascular disease, including. 16. Myocardial infarction or unstable angina within _6 months prior to the first study treatment. 17. New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF). 18. Serious cardiac arrhythmia requiring medication (with the exception of atrial fibrillation or paroxysmal supraventricular tachycardia). 19. Peripheral vascular disease _grade 3 (i.e.symptomatic and interfering with activities of daily living requiring repair or revision). 20. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to the first study treatment. 21. Non-healing wound, ulcer or bone fracture. Patients with granulating incisions healing by secondary intention with no evidence of facial dehiscence or infection are eligible but require three weekly wound examinations. 22. Serious active infection requiring i.v. antibiotics at enrolment. 23. Significant traumatic injury during the 4 weeks preceding the first dose of bevacizumab. 24. Known hypersensitivity to any of the study drugs or excipients (including cremophor and hamster Ovary cell products). 25. Evidence of any other medical conditions (such as psychiatric illness, peptic ulcer, etc.), physical examination or laboratory findings that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment related complications.
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