A Phase II Evaluation of Karenitecin in the Third-Line Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Frequency of objective response
研究概览
简要总结
Phase II trial to study the effectiveness of karenitecin in treating patients who have persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer that has not responded to platinum-based treatment. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
详细描述
OBJECTIVES:
I. Determine the antitumor activity of karenitecin in patients with persistent or recurrent platinum-resistant ovarian epithelial or primary peritoneal cancer.
II. Determine the toxicity of this drug in these patients.
OUTLINE: This is an open-label study.
Patients receive karenitecin IV over 1 hour on days 1-5. 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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed ovarian epithelial or primary peritoneal cancer
- •Recurrent or persistent disease
- •Platinum-resistant disease
- •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 to assess response (tumors within a previously irradiated field are designated as non-target)
- •Ineligible for a higher priority GOG study or other phase II cytotoxic study 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
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •ALT no greater than 2.5 times ULN
- •Alkaline phosphatase no greater than 2.5 times ULN
- •Creatinine no greater than 1.5 times ULN
- •No myocardial infarction within the past 6 months
- •No cerebrovascular accident within the past 6 months
- •No transient ischemic attack within the past 6 months
- •No uncontrolled hypertension
- •No decompensated or uncontrolled chronic heart failure
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No neuropathy (sensory or motor) grade 2 or greater
- •No other invasive malignancies within the past 5 years except nonmelanoma skin cancer
- •No active infection requiring antibiotics
- •At least 3 weeks since prior biological or immunological agents
- •See Disease Characteristics
- •At least 3 weeks since prior chemotherapy and recovered
- •No more than 2 prior cytotoxic chemotherapy regimens, with no more than 1 non-platinum, non-taxane regimen
- •No prior karenitecin or camptothecin analogue/derivative
- •At least 1 week since prior hormonal therapy
- •Concurrent hormone replacement therapy allowed
- •See Disease Characteristics
- •At least 3 weeks since prior radiotherapy and recovered
- •No prior radiotherapy to more than 25% of marrow-bearing areas
- •Recovered from recent surgery
- •At least 3 weeks since prior therapy directed at this malignancy
- •No prior anticancer therapy that would preclude study therapy
- •No concurrent amifostine or other protective reagents
排除标准
- 未提供
研究组 & 干预措施
Treatment
Patients receive karenitecin IV over 1 hour on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: Cositecan (Drug)
Treatment
Patients receive karenitecin IV over 1 hour on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: Pharmacological Study (Other)
结局指标
主要结局
Frequency of objective response
时间窗: Up to 6 years
Duration of objective response
时间窗: Up to 6 years
Frequency of observed adverse effects, graded according to CTC version 2.0
时间窗: Up to 6 years
Severity of observed adverse effects, graded according to CTC version 2.0
时间窗: Up to 6 years
Survival time for all patients
时间窗: Up to 6 years
Duration of progression-free interval for all patients
时间窗: Up to 6 years
次要结局
未报告次要终点