A Phase II Evaluation of CT-2103 in the Third-Line Treatment of Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Duration of progression-free interval
研究概览
简要总结
Phase II trial to study the effectiveness of CT-2103 in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
详细描述
PRIMARY OBJECTIVES:
I. Determine the antitumor activity of polyglutamate paclitaxel (CT-2103) as third-line treatment for patients with recurrent or persistent ovarian epithelial or primary peritoneal cancer.
II. Determine the nature and degree of toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive polyglutamate paclitaxel (CT-2103) IV over 10-20 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically confirmed recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer after second-line therapy
- •Received 1 prior platinum-based first-line chemotherapy regimen and 1 prior second-line (non-platinum, non-taxane) chemotherapy regimen
- •At least 1 unidimensionally measurable lesion
- •At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- •At least 1 target lesion that has not previously been irradiated
- •Ineligible for a higher priority GOG protocol (if one exists)
- •Ineligible for the currently active phase II cytotoxic protocol for platinum-resistant disease
- •Performance status - GOG 0-2
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •No active bleeding
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •SGOT no greater than 2.5 times ULN
- •Alkaline phosphatase no greater than 2.5 times ULN
- •PT or PTT less than ULN
- •Creatinine no greater than 1.5 times ULN
- •No uncontrolled hypertension
- •No uncompensated congestive heart failure
- •No symptomatic coronary artery disease
- •No myocardial infarction within the past 6 months
- •No sensory or motor neuropathy greater than grade 1
- •No active infection requiring antibiotics
- •No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •At least 3 weeks since prior biological therapy or immunotherapy directed at the malignancy
- •No prior polyglutamate paclitaxel (CT-2103)
- •Recovered from prior chemotherapy
- •At least 1 week since prior hormonal therapy directed at the malignancy
- •Concurrent hormone replacement therapy allowed
- •Recovered from prior radiotherapy
- •No prior radiotherapy to more than 25% of bone marrow
- •Recovered from prior surgery
- •At least 3 weeks since other prior therapy directed at the malignancy
- •No prior therapy for another malignancy that would preclude this study
- •No concurrent amifostine or other protective reagents
排除标准
- 未提供
研究组 & 干预措施
Treatment (polyglutamate paclitaxel)
Patients receive polyglutamate paclitaxel (CT-2103) IV over 10-20 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: Paclitaxel Poliglumex (Drug)
结局指标
主要结局
Duration of progression-free interval
时间窗: 5 years
Survival time
时间窗: 5 years
Frequency and duration of objective response
时间窗: 5 years
Frequency and severity of observed adverse effects
时间窗: 5 years
次要结局
- Change in observed adverse effects(Baseline to 5 years)
- Change in objective response(Baseline to 5 years)