EUCTR2008-008336-85-SE进行中（未招募）不适用
A single-arm Phase II clinical study investigating the addition of bevacizumab to carboplatin and weekly paclitaxel as first-line treatment in patients with epithelial ovarian cancer. - OCTAVIA
F. Hoffmann-La Roche Ltd.,Pharmaceuticals Division, PDR0 个研究点目标入组 180 人开始时间: 2009年4月22日最近更新:
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
- 180
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.Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient’s awareness and willingness to comply with the study requirements.
- •2.Female patients >=18 years of age.
- •3.Patients with histologically confirmed and documented, high risk International Federation of Gynecologic Oncology (FIGO) Stage I–IIa (only if grade 3 / poorly differentiated) or Stage IIb–IV (any grade) epithelial ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma.
- •Clear cell carcinoma regardless of the FIGO stage (clear cell carcinoma is defined as either =50% clear cell elements present or reported as clear cell carcinoma by the local pathologist).
- •Previous early stage epithelial ovarian or fallopian tube carcinoma treated with surgery alone. If the patient has abdomino-pelvic recurrence, they are eligible to participate in the trial as long as no further surgery is planned prior to disease progression.
- •4.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.1 There must be no planned surgical debulking prior to disease progression. 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
- •See protocol for further details.
- •5.ECOG Performance Status of 0–2.
- •6.Life expectancy of >= 12 weeks.
- •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.Non-epithelial Ovarian Cancer, including malignant mixed Müllerian tumours.
- •2.Ovarian tumours with low malignant potential
- •3.Previous systemic anti-cancer therapy for ovarian cancer.
- •4.History or evidence of synchronous primary endometrial carcinoma, unless all of the following criteria related to the endometrial carcinoma are met:
- •stage =Ib
- •no more than superficial myometrial invasion
- •no lymphovascular invasion
- •not poorly differentiated (grade 3 or papillary serous or clear cell carcinoma).
- •5.Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
- •6.Any prior radiotherapy to the pelvis or abdomen.
- •7.Surgery (including open biopsy) within 4 weeks prior to the first bevacizumab dose or planned during 13 months from the start of study treatment (including 12 months of bevacizumab therapy plus 4 weeks post-bevacizumab therapy).
- •8.Previous exposure to mouse CA-125 antibody.
- •9.Current or recent (within 10 days prior to the first study drug dose) chronic daily treatment with aspirin (>325 mg/day).
- •10.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 (except for line patency, in which case international normalized ratio [INR] must be maintained below 1.5).
- •11.Current or recent (within 30 days of first study dosing) treatment with another investigational drug or participation in another investigational study.
- •12.Planned intraperitoneal cytotoxic chemotherapy.
- •13.Inadequate bone marrow function: ANC: <1.5 x 109/l, or platelet count <100 x 109/l or Haemoglobin <9 g/dl. Patients may be transfused to maintain haemoglobin values =9 g/dl.
- •14.Inadequate coagulation parameters:
- •activated partial thromboplastin time (APTT) >1.5 xULN
- •INR >1.5
- •15. Inadequate liver function, defined as:
- •serum (total) bilirubin >1.5 x the upper limit of normal (ULN) for the institution
- •AST/SGOT or ALT/SGPT >2.5 x ULN.
- •16. Inadequate renal function, defined as:
- •serum creatinine >2.0 mg/dl or >177 micromol/l
- •urine dipstick for proteinuria >2+. Patients with >=2+ proteinuria on baseline dipstick analysis should undergo a 24-hour urine collection and must demonstrate =1g of protein in their 24-hour urine collection.
- •Prior or concomitant conditions or procedures:
- •17.Symptomatic CNS metastases
- •18.Pre-existing peripheral neuropathy =CTC grade 2.
- •19.Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start.
- •20.Women of childbearing potential (defined as <2 years after last menstruation and not surgically sterile) not using effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly) during the study and for 6 months after the last bevacizumab administration.
- •21. History or evidence of thrombotic or hemorrhagic disorders; including cerebrovascular accident (CVA) / stroke or transient ischemic attack (TIA) or sub-arachnoid haemorrhage within =6 months prior to the first study treatment).
- •22.Uncontrolled hypertension (sustained systolic >150 mm Hg and/or diastolic >100 mm Hg despite antihypertensive therapy) or clinically signif
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