EUCTR2012-005050-35-NL进行中（未招募）1 期
Phase Ib/II study of metformin in combination with carboplatin/paclitaxel chemotherapy in patients with advanced ovarian cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 124
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
- •Inclusion criteria
- •Patients with advanced stage (FIGO III-IV), histologically confirmed and documented epithelial ovarian carcinoma
- •Patients eligible for neoadjuvant carboplatin/paclitaxel chemotherapy prior to surgical debulking (phase 1 or 2) OR patients with relapsed or progressive ovarian cancer after first line treatment eligible for palliative carboplatin/paclitaxel chemotherapy (phase 1 only)
- •If an exploratory laparotomy was performed at diagnosis, patients are only eligible if aggressive tumour debulking procedures were not performed. Only minimal tumour resection for the purpose of diagnosis and palliation are allowed. Aggressive tumour debulking procedures include total abdominal hysterectomy, bilateral salpingo-oophorectomy and omentectomy, with or without lymphadenectomy (phase 2 only)
- •Measurable tumour according to RECISTv1.1 or GCIG CA125 criteria (phase 2 only)
- •Eastern Cooperative Oncology Group-performance status (ECOG-PS) of 0-2
- •Age = 18 years
- •Laboratory Requirements - within 7 days prior to enrolment:
- •absolute neutrophil count [ANC] =1.5 x 109/L
- •platelets > 100 x 109/L
- •haemoglobin >9g/dl. Patients may be transfused or use erythropoietin to maintain haemoglobin values = 9 g/dl.
- •hepatic function: bilirubin =1.5×upper limit of normal (ULN), AST/ALT=2.5×ULN
- •estimated creatinine clearance = 60ml/min
- •Before patient registration/randomization, written informed consent for the trial must be given according to ICH/GCP, and national/local regulations.
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Exclusion criteria
- •Prior chemotherapy, immunotherapy, targeted agents or radiotherapy to abdomen or pelvis (phase 2 only)
- •Current or recent (within 30 days of first study dosing) treatment with another investigational drug or participation in another investigational study.
- •Metformin within 4 weeks prior to enrolment.
- •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 (phase 2 only)
- •Symptomatic CNS metastasis
- •Pre-existing peripheral neuropathy = CTC grade 2.
- •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.
- •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 study medication.
- •Known hypersensitivity to any of the study drugs or excipients.
- •Serious active infection requiring i.v. antibiotics at enrolment.
- •Unstable medical conditions.
- •Evidence of any other medical conditions, 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.
研究者
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