EUCTR2004-004515-26-DE进行中（未招募）不适用
An open-label, multicenter, randomized phase II study to compare the effects of Paclitaxel/Carboplatin and Lonafarnib to those of Paclitaxel/Carboplatin for 1st line treatment of patients with epithelial ovarian cancer FIGO stages IIB-IV
GYN Research GmbH0 个研究点目标入组 100 人开始时间: 2005年9月8日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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
- •- 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 defined as
- •WBC > 3.0 x 10 9/lNeutrophils (ANC) >= 1,5 x 10 9/l
- •Platelets >= 100 x 10 9/lHemoglobin > 6 mmol/l (> 10,0 g/dl)
- •Bilirubin <= 1 x upper limit of normal range
- •AST and ALT < 1.5 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 <= 6 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
- •- Ovarian tumors of low malignant potential (borderline tumors)
- •- Non-epithelial ovarian or mixed epithelial/non epithelial 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-CTC 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 have used any investigational drugs within 30 days of study entry
- •- 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.
研究者
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