NCT00382811已完成3 期
Multi-Center, Randomized, Double-Blind, Phase III Efficacy Study Comparing Phenoxodiol in Combination With Carboplatin Versus Carboplatin With Placebo in Patients With Platinum-Resistant or Platinum-Refractory Late-Stage Epithelial Ovarian, Fallopian or Primary Peritoneal Cancer Following at Least Second Line Platinum Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 70
- 主要终点
- The primary efficacy end-point is progression-free survival (PFS). PFS is the time from randomization until disease progression or death
研究概览
简要总结
The purpose of this project is to see if weekly carboplatin compared with phenoxodiol in combination with weekly carboplatin, is effective against late stage ovarian cancer and to see what, if any, side-effects of treatment may result.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Histologically-confirmed ovarian, fallopian, or primary peritoneal carcinoma of epithelial origin
- •Recurrent or persistent advanced disease
- •Have measurable disease
- •Undergone at least two courses of therapy with a platinum drug (cisplatin or carboplatin) and have responded to the first of those courses of therapy as determined by either Response Evaluation Criteria in Solid Tumors (RECIST) or Gynecologic Cancer Intergroup (GCIG) criteria
- •Disease relapse as determined by either RECIST or GCIG criteria within 6 months of completion of the second or greater course of platinum therapy using a 2-, 3- or 4-weekly regimen and platinum-free interval of no greater than 6 months at the time of enrollment, being the time taken from the last day of platinum therapy
- •Any number of previous courses of platinum therapy or non-platinum therapy
- •Likely to survive at least 3 months
- •Karnofsky performance score of at least 60%
- •Have adequate physiological function without evidence of major organ dysfunction as evidenced by:
- •serum creatinine < 1.5 mg/dl
- •serum transaminase levels ≤ 3 x the upper limit of normal (ULN) for the reference laboratory and
- •bilirubin level < ULN
- •Have adequate hematological function defined by:
- •platelets > 100,000/mm3
- •white cell counts (WCC) > 3,000/mm3
- •neutrophils > 1,500/mm3
- •hemoglobin > 8.0 g/dl
- •Aged > 18
- •Be able to understand the risks and benefits of the study and give written informed consent to participation.
排除标准
- •Patients with mucinous histological type of ovarian cancer
- •Patients who have failed to show a clinical response (RECIST or GCIG criteria) to at least one prior course of platinum therapy
- •Patients with active infection
- •Patients with concurrent severe and/or uncontrolled medical disease (e.g., uncontrolled diabetes, hypertension, ischemic heart disease, congestive heart failure, etc.)
- •Patients with a history of chronic active hepatitis or cirrhosis
- •Patients with HIV
- •Patients with active central nervous system (CNS) metastases. Patients with known CNS metastases must have received prior radiation therapy, and CNS metastatic disease must be stable for 4 weeks.
- •Patients who have not recovered from the acute effects of any prior anti-neoplastic therapy
- •Patients with known hypersensitivity to platinum drugs that cannot be managed with concomitant medication.
研究组 & 干预措施
1
Experimental
Daily Phenoxodiol + weekly carboplatin
干预措施: phenoxodiol (Drug)
1
Experimental
Daily Phenoxodiol + weekly carboplatin
干预措施: carboplatin (Drug)
2
Active Comparator
Daily phenoxodiol placebo + weekly carboplatin
干预措施: carboplatin (Drug)
2
Active Comparator
Daily phenoxodiol placebo + weekly carboplatin
干预措施: placebo (Drug)
结局指标
主要结局
The primary efficacy end-point is progression-free survival (PFS). PFS is the time from randomization until disease progression or death
时间窗: Progression Free Survival
次要结局
- The secondary efficacy end-point is overall survival (OS)(Overall survival)
研究者
研究点 (70)
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