A Phase II Randomized Trial of Erlotinib or Vinorelbine in Chemo-naive, Advanced, Non-Small-Cell Lung Cancer Patients Aged 70 Years or Older in Taiwan
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 114
- 主要终点
- Percentage of Participants Achieving a Best Overall Response of Complete Response (CR) or Partial Response (PR)
研究概览
简要总结
This study will compare the efficacy and safety of Tarceva (erlotinib) and vinorelbine in chemo-naive elderly patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva (150 mg po daily) or vinorelbine (60 mg/m2 on days 1 and 8 of cycle 1 and 80 mg/m2 for the other 21 days cycles). The anticipated time on study treatment is until disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, >=70 years of age
- •Non-small cell lung cancer
- •Naive to prior chemotherapy or specific immunotherapy
- •Presence of at least 1 measurable lesion
排除标准
- •Active non-controlled infection or disease
- •CNS metastases
- •Any other malignancies (other than adequately treated basal cell cancer of skin, or in situ cancer of the cervix)
研究组 & 干预措施
1
干预措施: erlotinib [Tarceva] (Drug)
2
干预措施: vinorelbine (Drug)
结局指标
主要结局
Percentage of Participants Achieving a Best Overall Response of Complete Response (CR) or Partial Response (PR)
时间窗: Screening, Day 1 of Cycles 3 and 5 and at End of treatment up to 1 year
CR was defined as disappearance of all target lesions. PR was defined as at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Participants experiencing either a CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST) were classified as responders. Participants with tumour assessment unevaluable were viewed as non-responders.
次要结局
- Duration of Response Among Participants Who Achieved Either a CR or PR(Screening, Day 1 of Cycles 3 and 5, every 4th cycle during post-study treatment, and every 3 cycles during follow-up)
- Time to Disease Progression(Day 1 of Cycles 1, 3, and 5 or first documentation of progressive disease or death)
- Overall Survival: Time to Event(Day 1 of Cycles 1 through 6 to date of death or date of last follow-up assessment)
- Changes in Quality of Life as Measured by the FACT Questionnaire(Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study)
- Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT) Questionnaire(Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study)
- Percentage of Participants Achieving Disease Control(Screening, Day 1 of Cycles 3 and 5 and at End of treatment up to 1 year)
- Percentage of Participants With Changes in Quality of Life as Measured by FACT Questionnaire Scores by Category of Change(Baseline and End of study)
- Percentage of Participants With Changes in FACT-L (Lung Symptoms) by Category of Change(Baseline and End of study)
- Percentage of Participants With Disease Progression(Day 1 of Cycles 1, 3, and 5 or first documentation of progressive disease or death)
- Overall Survival: Percentage of Participants With an Progressive Disease or Death(Day 1 of Cycles 1 through 6 to date of death or date of last follow-up assessment)
- Changes in Quality of Life as Assessed by FACT-L (Lung Symptoms) Questionnaire(Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study)