Phase II Trial of XL119 (Rebeccamycin Analogue) in Relapsed "Sensitive" Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Objective Response Rate Estimated as the Proportion of Responders
研究概览
简要总结
Drugs used in chemotherapy, such as rebeccamycin analog, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well rebeccamycin analog works as second-line therapy in treating patients with limited-stage or extensive-stage small cell lung cancer that has relapsed after previous first-line chemotherapy.
详细描述
OBJECTIVES:
I. Determine the objective response rate in patients with limited or extensive stage small cell lung cancer that relapsed after prior first-line chemotherapy when treated with rebeccamycin analogue as second-line therapy.
II. Determine the duration of remission and survival of patients treated with this drug.
III. Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of small cell lung cancer (SCLC)
- •Limited or extensive stage
- •At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- •Sensitive* relapsed disease after only 1 prior chemotherapy regimen
- •Brain metastasis allowed provided the following criteria are met:
- •Stable brain disease
- •Not receiving irradiation
- •No steroid requirement to control symptoms
- •Performance status - ECOG 0-2
- •Performance status - Karnofsky 60-100%
- •At least 12 weeks
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 9.0 g/dL
- •AST and ALT < 2.5 times upper limit of normal (ULN) (5 times ULN if liver involvement is present)
- •Bilirubin ≤ 1.5 mg/dL
- •Creatinine < 2.0 mg/dL
- •Creatinine clearance ≥ 60 mL/min
- •No New York Heart Association class III or IV heart disease
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No active or ongoing infection
- •No other concurrent uncontrolled illness
- •No psychiatric illness or social situation that would preclude study compliance
- •See Disease Characteristics
- •See Disease Characteristics
- •See Disease Characteristics
- •Prior radiotherapy allowed
- •No other concurrent investigational agents
- •No other concurrent therapies for SCLC
- •No concurrent combination antiretroviral therapy for HIV-positive patients
排除标准
- 未提供
研究组 & 干预措施
Treatment (becatecarin)
Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: becatecarin (Drug)
结局指标
主要结局
Objective Response Rate Estimated as the Proportion of Responders
时间窗: Up to 4 years
Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD):At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. An exact binomial 95% confidence interval will be calculated for this proportion.
Progression Free Survival
时间窗: Up to 4 years
Median time of patients without Progressive Disease (PD):At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Duration of remission will be analyzed using Kaplan-Meier curves.
Overall Survival
时间窗: Up to 4 years
Median time of patient survival. Duration of survival will be analyzed using Kaplan-Meier curves.
次要结局
- Progression Free Survival(6 months)
- Overall Survival(1 year)