Open Label Phase II Study on RFS 2000 (9-Nitro-camptothecin, 9-NC) Administered as a "5 Days On-2 Days Off" Oral Treatment in Advanced Ovarian Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 13
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have advanced ovarian cancer.
详细描述
OBJECTIVES:
- Determine the objective response rate and duration of response in patients with advanced ovarian cancer treated with nitrocamptothecin.
- Determine the probability of objective response as expressed by the response rate in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to disease status (sensitive vs refractory).
Patients receive oral nitrocamptothecin daily for 5 consecutive days each week for 3 weeks. Treatment continues every 3 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve stable disease (SD) receive up to 4 additional courses past SD. Patients who achieve partial response (PR) or complete response (CR) receive a minimum of 2 additional courses past PR or CR.
Patients are followed every 6 weeks until disease progression or the initiation of another antitumor therapy.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Histologically proven metastatic or unresectable locally advanced progressive ovarian cancer that has failed first line platinum and taxane based regimen
- •Refractory disease defined by a relapse within 1 year after completion of first line therapy
- •Sensitive disease defined by a relapse greater than 1 year after completion of first line therapy
- •Minimum of 1 target lesion that can be accurately measured in at least 1 dimension
- •At least 20 mm by conventional techniques OR
- •At least 10 mm by spiral CT scan
- •No symptomatic brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •Neutrophil count at least 2,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin less than 1.5 times upper limit of normal (ULN)
- •Alkaline phosphatase, SGOT, and SGPT no greater than 2.5 times ULN (no greater than 5 times ULN if hepatic metastases present)
- •Creatinine no greater than 1.7 mg/dL
- •Cardiovascular:
- •No ischemic heart disease within the past 6 months
- •Normal 12 lead electrocardiogram
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No unstable systemic disease or active uncontrolled infections
- •No other prior or concurrent malignancy except adequately treated basal cell or squamous cell skin cancer or cone biopsied carcinoma of the cervix
- •No psychological, familial, sociological, or geographical condition that would preclude compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent filgrastim (G-CSF) with nitrocamptothecin
- •Chemotherapy:
- •See Disease Characteristics
- •Greater than 4 weeks since prior chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Greater than 4 weeks since prior radiotherapy
- •Greater than 2 weeks since prior major surgery
- •No other concurrent anticancer agents
- •No other concurrent investigational therapy
排除标准
- 未提供