CTRI/2011/06/001824已完成3 期
Global study to assess the addition of bevacizumab to carboplatin and paclitaxel as front-line treatment of epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma - ROSiA
F HoffmannLa Roche Ltd0 个研究点目标入组 1,000 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Adult female patients with ECOG PS of 0, 1 or 2 and minimum life expectancy 3 months.
- •Histologically confirmed and documented high risk FIGO Stage I/IIa (only if grade 3 / poorly differentiated)
- •Stage IIb/IV (any grade) epithelial ovarian carcinoma, fallopian tube carcinoma, primary peritoneal carcinoma
- •Histologically confirmed and documented clear cell carcinoma regardless of the FIGO stage (defined as either 50% clear cell elements present or reported as clear cell carcinoma by the local pathologist).
- •Histologically confirmed and documented carcinosarcoma.
- •Patients with recurrent ovarian cancer that have been previously treated with surgery alone for their early stage disease are eligible.
- •Patients should have already undergone surgical debulking, by a surgeon experienced in the management of ovarian cancer, with the aim of maximal surgical cytoreduction according to the GCIG Conference Consensus Statement.
- •Patients with stage III and IV disease in whom initial surgical debulking was not appropriate will still be eligible providing
- •-the patient has a histological diagnosis and
- •-debulking surgery prior to disease progression is not foreseen
- •Eligible for carboplatin (or cisplatin) and paclitaxel chemotherapy treatment in accordance with local standards of care following cytoreductive surgery.
- •Patients who have received neo-adjuvant chemotherapy may be included.
排除标准
- •Patients with - non-epithelial ovarian cancer or Ovarian tumors with low malignant potential (i.e. borderline tumors)
- •-no more than superficial myometrial invasion
- •-no lymphovascular invasion
- •-not poorly differentiated (grade 3 or papillary serous or clear cell carcinoma).
- •Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure
- •Prior, current or planned treatment
- •Previous systemic therapy for ovarian cancer (i.e. chemo-, immuno-, hormonal, monoclonal antibody or tyrosine kinase inhibitor therapy). Prior neo-adjuvant chemotherapy is allowed.
- •Planned intraperitoneal cytotoxic chemotherapy.
- •Radiotherapy within 28 days of Day 1, Cycle 1.
- •Inadequate bone marrow function:
- •-absolute neutrophil count < 1.5 x 109/L
- •-platelet count < 100 x 109/L or
- •-Hb < 9 g/dL.
- •Inadequate liver function:
- •-serum (total) bilirubin > 1.5 x ULN
- •-AST & ALT > 2.5 x ULN (> 5 x ULN in patients with liver metastases) or
- •-alkaline phosphatase > 2.5 x ULN (or > 5 x ULN in case of liver metastases or > 10 x ULN in case of bone metastases).
- •Inadequate renal function:
- •-Serum creatinine >2.0 mg/dl (> 177 µmol/L)
- •-Urine dipstick for proteinuria should be < 2+.
- •History of myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA) within 6 months prior to Day 1, Cycle 1.
- •Uncontrolled hypertension (current systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 100 mm Hg) or history of hypertensive crisis or hypertensive encephalopathy.
- •Clinically significant (i.e. active) cardiovascular disease (e.g. NYHA Class II or greater congestive heart failure, aortic aneurysm).
- •History or evidence upon physical/neurological examination of central nervous system (CNS) disease
研究者
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