A Multicenter, Randomised, Double-Blind, Phase 3 Study Of Sunitinib In Metastatic Colorectal Cancer Patients Receiving Irinotecan, 5-Fluorouracil And Leucovorin (FOLFIRI) As First Line Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 768
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
The purpose of the study is to evaluate the safety and efficacy of FOLFIRI (Irinotecan, Leucovorin and 5 Fluorouracil) chemotherapy when combined with sunitinib or FOLFIRI chemotherapy without adding sunitinib as the first line treatment of patients with metastatic colorectal cancer.
详细描述
On June 25, 2009, the independent Data Monitoring Committee (DMC) reviewed the progress of Study A6181122. The DMC determined Study A6181122 had met pre-specified futility criteria and was unlikely to meet its primary endpoint to demonstrate a statistically significant improvement in progression-free survival (PFS) in patients treated with sunitinib plus FOLFIRI versus placebo plus FOLFIRI. No new safety findings were noted. Pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings. Patients receiving benefit on treatment as determined by the investigator may remain on study.
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
- Double (Participant, Investigator)
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
- •Confirmed (histologically or cytologically) colorectal adenocarcinoma with metastatic disease.
- •Not received previous therapy for metastatic colorectal disease but for whom FOLFIRI treatment is clinically indicated.
- •Adequate organ function defined by blood test.
排除标准
- •History of another primary cancer in the last 3 years.
- •Previous full field radiotherapy within the last 4 weeks or limited field radiotherapy within 2 weeks of enrolling into the study. Or previous radiation treatment of more that 30% of the bone marrow.
- •History of presence of brain metastasis, spinal cord compression carcinomatous meningitis or leptomeningeal disease.
研究组 & 干预措施
2
干预措施: irinotecan (Drug)
1
干预措施: 5 fluorouracil (Drug)
1
干预措施: irinotecan (Drug)
1
干预措施: levo- leucovorin (Drug)
1
干预措施: sunitinib (Drug)
2
干预措施: 5 fluorouracil (Drug)
2
干预措施: levo- leucovorin (Drug)
2
干预措施: placebo (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: First dose of study treatment up to 30 months
PFS defined as time from date of randomization to date of first documentation of objective tumour progression or death due to any cause, whichever occurred first.
次要结局
- Overall Survival (OS)(Baseline up to 30 months)
- Number of Participants With Overall Confirmed Objective Response(Day 28 of Cycle 1 up to 30 months)
- Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Assessment Inventory of Gastrointestinal Symptoms (MDASI-GI) Symptom Intensity Score(Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until end of treatment (EOT)/withdrawal)
- Change From Baseline in European Quality of Life (EuroQol) EQ-5D Self-Report Questionnaire(Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal)
- Change From Baseline in EuroQol (EQ) Visual Analog Scale (VAS) (EQ-VAS)(Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal)
- Change From Baseline in MDASI-GI Symptom Interference Score(Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal)
- Duration of Response (DR)(Day 28 of Cycle 1 up to 30 months)