ACTRN12605000432617已完成1 期
Multi-Center, Phase Ib/IIa Safety and Preliminary Efficacy Study of Phenoxodiol (Intravenous Dosage Form and Oral Dosage Form) as a Chemo-Sensitizing Agent for Cisplatin, Carboplatin and Paclitaxel in Epithelial Ovarian Cancer or Primary Peritoneal Cancer that is Platinum- and/or Taxane-Refractory or Resistant.
Marshall Edwards Pty Ltd0 个研究点目标入组 100 人开始时间: 2005年9月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 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
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 ot stated（—）
- 性别
- Female
入选标准
- •a) Patients must have histological evidence of epithelial ovarian, fallopian or primary peritoneal carcinoma and have been previously surgically stagedb) Patients must have received less than or equal to 4 prior chemotherapy regimens for this malignancyc) Patients must have been treated previously with a taxane (paclitaxel or taxotere) and/or platinum (cisplatin or carboplatin) and be considered refractory or resistant to either or both therapies based on the following: have had a treatment free interval following platinum or paclitaxel of less than 6 months or have progressed during platinum or paclitaxel-based therapy.d) Patients must have either measurable or evaluable disease by the following criteria:Measurable disease is defined as having at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded) allowing a response to be determined by the RECIST criteria. Each lesion must be greater than 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or greater 10 mm when measured by spiral CT. Patients with evaluable disease must have experienced doubling of blood levels of CA125 in the six (6) months leading up to enrollment in the study and have a CA125 level at least two times greater than the institutional upper limit of normal values, within 1 week of study entry.e) Patients must be > 18 years of age and must be able to understand the risks and benefits of the study and to be able to give written informed consent to participationf) Patients must have a Karnofsky Performance Score of at least 60%g) Patients must be off any standard therapy directed at the malignant tumor for at least 4 weeks, and in the case of any investigational anti-cancer drugs, for at least 6 monthsh) Patients should be free of active infection requiring antibioticsi) Patients of childbearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraceptionj) Patients must have; Renal function: creatinine levels less than 1.5 x institutional upper limit normal (ULN) (equivalent to Common Toxicity Criteria (CTC) Grade 1)Hepatic function: bilirubin levels less than 1.5 x ULN (CTC Grade 1); SGOT and alkaline phosphatase less than 2.5 x ULN (CTC Grade 1)Bone marrow function: platelets > 100x109/L , WCC > 3x109/L, Hb > 8g/dL, neutrophils > 1.5 x 109 /LNeurological function: neuropathy (sensory and motor) less than or equal to CTC Grade 1.k) Patients must have signed an approved informed consent.
排除标准
- •No exclusion criteria
研究者
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