NCT00281515已完成2 期
An Open-label, Multicenter, Randomized Phase II Study to Compare the Effects of Paclitaxel/Carboplatin and Lonafarnib to Those of Paclitaxel/Carboplatin for First-line Treatment of Patients With Epithelial Ovarian Cancer FIGO Stages IIB-IV
AGO Study Group22 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2006年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 22
- 主要终点
- Progression-free survival
研究概览
简要总结
The purpose of this study is to compare the effects of Paclitaxel/Carboplatin and Lonafarnib to those of Paclitaxel/Carboplatin in primary treatment of patients with epithelial ovarian cancer.
详细描述
Today the standard therapy for patients with advanced ovarian carcinoma is paclitaxel and carboplatin. Lonafarnib is a farnesyl transferase inhibitor (FTI) that is active against a broad spectrum of tumor cell lines in vitro and tumor xenografts in nude mice. Lonafarnib has single-agent antitumor activity as well as enhanced activity in combination with taxanes in a number of tumor cell lines and in vivo models.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Previously untreated patients with a histologically confirmed diagnosis of cancer of the ovary, the fallopian tube or extra-ovarian papillary serous tumors FIGO stage IIB-IV, regardless of measurable or non-measurable disease
- •Age >= 18 years
- •ECOG performance status <= 2
- •Life-expectancy of at least 6 months
- •Adequate bone marrow, renal and hepatic function:
- •WBC >= 3.0 x 10^9/l; Neutrophils (ANC) >= 1.5 x 10^9/l; Platelets >= 100 x 10^9/l; Hemoglobin > 6 mmol/l (> 10.0 g/dl); Bilirubin <= 1 x upper limit of normal range; Alkaline phosphatase <= 2.5 x upper limit of normal range; estimated GFR >= 50 ml/min according to Jelliffe or Cockroft-Gault formula
- •Patients who have given their signed and written informed consent to participate in the trial after fully understanding the implication and constraints of the protocol
- •Patients must be geographically accessible for treatment and follow-up
- •Time between definitive surgery and randomization into the study <= 6 weeks
排除标准
- •Ovarian tumors of low malignant potential (borderline tumors)
- •Non-epithelial ovarian or mixed epithelial/nonepithelial tumors (e.g. Mixed Mullerian tumors)
- •Patients who have received previous chemotherapy or radiotherapy
- •Prior treatment with FT inhibitors
- •Patients with a prior diagnosis of any malignancy not cured by surgery alone less than 5 years before study entry (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
- •Complete bowel obstruction or the presence of symptomatic brain metastases
- •Concurrent severe medical problems unrelated to malignancy which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy
- •Patients with a history of seizure disorder or central nervous system disorders; pre-existing motor or sensory neurologic pathology or symptoms > NCI grade 1
- •History of congestive heart failure (NYHA Classification > 2, even if medically controlled.
- •History of clinical and electrocardiographically documented myocardial infarction within the last 6 months.
- •History of atrial or ventricular arrhythmias (>= LOWN II)
- •Patients with significant Fridericia QTc (QTcF) prolongation at Baseline (ie. QTcF >= 470 msec)
- •Patients with severe active infection
- •Patients with a history of severe hypersensitivity reactions to products containing Cremophor EL (cyclosporin or vitamin K) and/or patients with known hypersensitivity to compounds chemically related to Carboplatin and Paclitaxel
- •Women with childbearing potential and who are sexually active and unwilling to use a medically acceptable method of contraception (oral contraceptive, diaphragm with spermicide, intrauterine device, condom with spermicide)
- •Women who are pregnant or breast feeding
- •Administration of other anticancer therapy or simultaneous chemotherapeutic and/or hormonal drugs, or radiotherapy during the study treatment period (except: hormonal replacement therapy and/or steroid antiemetics)
- •Patients who are participating in any other clinical study
- •Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent
研究组 & 干预措施
Lonafarnib / Paclitaxel /Carboplatin
Experimental
干预措施: Lonafarnib (Drug)
Paclitaxel/Carboplatin
Other
Standard Chemotherapy
干预措施: Lonafarnib (Drug)
结局指标
主要结局
Progression-free survival
时间窗: every 3 months until PD
次要结局
- Objective tumor response rate (CR/PR (RECIST))(During whole trial)
- Duration of response(Until Progression of disease)
- Overall survival(Until date of death)
- safety based on nature, frequency and severity of adverse events(During treatment phase until resolution)
- Predose lonafarnib concentrations(During treatment)
- PD activity(Assessment)
研究者
研究点 (22)
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