NCT00698516已完成2 期
An Open-label, Multicenter, Non-comparative, Phase II Study of Oral Topotecan in Combination With Bevacizumab for Second-line Treatment in Subjects With Relapsed Small-cell Lung Cancer (SCLC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Progression-free Survival (PFS) at 3 Months
研究概览
简要总结
Combination of Hycamtin (topotecan) and Avastin (bevacizumab) could allow killing of both endothelial and neoplastic cells. We postulate that addition of bevacizumab to topotecan will increase delivery of topotecan to tumor cells and may enhance activity of topotecan in patients with previously treated small cell lung cancer and improve progression free survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Histologically or cytologically confirmed diagnosis of SCLC.
- •First recurrence of SCLC after therapy with one prior chemotherapy regimen at initial diagnosis.
- •Relapsed SCLC of any duration (both sensitive and resistant relapse).
- •ECOG performance status of </=
- •Adequate bone marrow reserve, hepatic, renal, and cardiovascular function.
- •No prior therapy with bevacizumab or any other VEGF inhibitor or topotecan
排除标准
- •Uncontrolled emesis, regardless of etiology.
- •Active uncontrolled infection.
- •GI conditions or drugs that could impact absorption of oral topotecan.
- •Known hypersensitivity to any component of topotecan capsule or compounds chemically related to topotecan.
- •Uncontrolled hypertension with BP>150/
- •Prior h/o hypertensive crisis or encephalopathy.
- •NYHA Grade II or greater congestive heart failure.
- •H/O myocardial infarction within 6 months.
- •H/O stroke or TIA within 6 months.
- •H/O thrombotic or hemorrhagic disorders.
- •Clinically significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months.
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days.
- •Anticipation of need for major surgical procedure during the study.
- •Minor surgical procedures within 7 days prior to treatment start (placement of vascular access devices is permitted).
- •H/O abdominal fistula, GI perforation, or intra-abdominal abscess within prior 6 months. Serious, non-healing wound, active ulcer, or untreated bone fracture. - H/O hemoptysis within prior 1 month.
- •Concurrent radiotherapy.
- •H/O whole lung radiation within 90 days prior to start of treatment.
- •Presence or h/o central nervous system or brain metastases.
- •H/o another malignancy other than SCLC.
- •Concurrent chemotherapy, immunotherapy, or investigational therapy for the treatment of small cell lung cancer.
研究组 & 干预措施
Open label, Single arm
Experimental
Oral topotecan + IV Bevacizumab
干预措施: Oral Hycamtin (topotecan) Capsules + IV Avastin (bevacizumab) (Drug)
结局指标
主要结局
Percentage of Participants With Progression-free Survival (PFS) at 3 Months
时间窗: 3 months
PFS = time from initiation of drug to time of first disease progression/death due to any cause. Progression assessed using Response Evaluation Criteria (RECIST): \>=20% increase in sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since treatment started, or appearance of new lesion(s). If participant did not progress or die, the time of initiation of post-treatment anti-cancer therapy or time of last contact used. PFS at 3 months calculated by taking the Kaplan-Meier (KM) estimate at 90 days from the initiation of treatment. SE = standard error.
次要结局
- PFS - Overall(Baseline to disease progression or death (up to 82.4 weeks))
- Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)(Baseline to disease progression or death (up to 82.4 weeks))
- Number of Participants With a Tumor Response (CR and PR)(Baseline to disease progression or death (up to 82.4 weeks))
- Duration of Tumor Response (CR and PR)(Baseline to disease progression or death (up to 82.4 weeks))
- Time to Tumor Response (CR and PR)(Baseline to disease progression or death (up to 82.4 weeks))
- Overall Survival(Baseline to disease progression or death (up to 82.4 weeks))
研究者
研究点 (1)
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