Randomized Non Comparative Phase II Trial With Bevacizumab and Fotemustine in the Treatment of Recurrent Glioblastoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 91
- 主要终点
- Percentage of Participants Alive 6 Months After Start of Treatment
研究概览
简要总结
This randomized, non-comparative study will evaluate the efficacy and safety of Avastin (bevacizumab) in patients with recurrent glioblastoma. Patients will be randomized to receive Avastin 10 mg/kg intravenously every 2 weeks or fotemustine 75 mg/m2 on days 1, 8 and 15, followed by, after a 5 weeks interval, 100 mg/m2 intravenously every 3 weeks. Treatment with fotemustine serves as a calibration arm and no formal efficacy comparison will be made between the two treatment arms. The anticipated time of study treatment is until disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Adult patients, >/=18 years of age
- •Diagnosis of recurrent glioblastoma multiforme (Grade IV)
- •Previous treatment with temozolomide and radiotherapy
- •First recurrence after standard adjuvant treatment (surgery, followed by radiotherapy and chemotherapy)
- •Adequate hematological, biochemical and organ functions
排除标准
- •Previous treatment with Avastin or other anti-angiogenic drugs
- •Residual relevant toxicity resulting from previous therapy
- •Radiotherapy within the 3 months prior to the diagnosis of disease progression
- •Chemotherapy in the previous 4 weeks
- •Other active or inactive malignancies (except for carcinoma in situ of the cervix, of the prostate or basal cell carcinoma)
- •Clinically significant cardiovascular diseases
研究组 & 干预措施
Calibration Arm
干预措施: fotemustine (Drug)
Investigational Arm
干预措施: bevacizumab [Avastin] (Drug)
结局指标
主要结局
Percentage of Participants Alive 6 Months After Start of Treatment
时间窗: 6 months
Overall survival (OS) was defined as the time in months from the start of treatment to death due to any cause. If a participant was not known to have died, time was censored at the last date the participant was known to be alive, which was defined as the latest among date of last visit, date of last sample collected for laboratory exam, date of magnetic resonance imaging (MRI) assessment, date of last treatment, date of discontinuation and date of last available follow-up visit. Participants with no information after baseline were censored at Day 1. OS was estimated by the Kaplan-Meier method.
Overall Survival (OS)
时间窗: Baseline until death (up to 691 days)
OS was defined as the time in months from the start of treatment to death due to any cause. If a participant was not known to have died, time was censored at the last date the participant was known to be alive, which was defined as the latest among date of last visit, date of last sample collected for laboratory exam, date of MRI assessment, date of last treatment, date of discontinuation and date of last available follow-up visit. Participants with no information after baseline were censored at Day 1. OS was estimated by the Kaplan-Meier method.
次要结局
- Percentage of Participants Who Were Alive and Progression Free 6 Months After Start of Treatment(6 months)
- Progression-Free Survival (PFS)(Baseline until disease progression or death (baseline, 46 days after first administration of study drug, and thereafter every 56 days up to 691 days))
- Percentage of Participants Alive 9 Months After Start of Treatment(9 months)
- Percentage of Participants Alive 12 Months After Start of Treatment(12 months)
- Percentage of Participants Alive 30 Days After Last Dose of Study Drug(30 days after last dose of study drug (up to Day 600))
- Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR)(Baseline until disease progression or death (baseline, 46 days after first administration of study drug, and thereafter every 56 days up to 691 days))
- Change From Screening in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores at Weeks 8, 16, 24, 32, 40, 48, 56, 64, and 72(Screening, Weeks 8, 16, 24, 32, 40, 48, 56, 64, and 72)
- Percentage of Participants With Corticosteroid Initiation During the Study Period(Baseline until recurrence (up to 691 days))
- Time to Corticosteroid Initiation(Baseline until recurrence (up to 691 days))
- Percentage of Participants in Each Class of Corticosteroid Use(Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, post-treatment follow-up (up to Day 691))
- Percentage of Participants With Karnofsky Performance Status (KPS) Deterioration(Baseline until KPS deterioration (up to 691 days))
- Time to Karnofsky Performance Status (KPS) Deterioration(Baseline until KPS deterioration (up to 691 days))
- Percentage of Participants With World Health Organization (WHO) Performance Status (PS) Deterioration(Baseline until WHO PS deterioration (Up to 691 days))
- Time to WHO PS Deterioration(Baseline until WHO PS deterioration (Up to 691 days))