A Randomized, Phase 2B Study Of Sunitinib Plus Oxaliplatin, 5-Fluorouracil And Leucovorin (FOLFOX) Versus Bevacizumab Plus FOLFOX As First-Line Treatment In Patients With Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 191
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
This study will compare the safety and efficacy of sunitinib in combination with FOLFOX versus bevacizumab in combination with FOLFOX for the treatment of patients with metastatic colorectal cancer who have not been treated before.
详细描述
The study was terminated on April 26, 2010 due to lack of efficacy, as determined during the interim analysis of data in April 2010, showing that the study did not meet its primary endpoint to demonstrate a statistically significant improvement in PFS. The decision to terminate the trial was not based on any safety concerns.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adenocarcinoma of the colon or rectum with locally advanced or metastatic disease
- •Evidence of measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST)
- •Eastern Cooperative Oncology Group (ECOG) 0 or 1
排除标准
- •Previous treatment with Sutent, Avastin, or any other systemic therapy for locally advanced or metastatic colorectal cancer
- •Less than 6 months since completion of adjuvant chemotherapy to documentation of recurrent disease
- •History of cardiac disease
- •Brain mets
研究组 & 干预措施
A
Treatment arm A - sunitinib plus mFOLFOX6
干预措施: sunitinib (Drug)
A
Treatment arm A - sunitinib plus mFOLFOX6
干预措施: mFOLFOX6 (Drug)
B
Treatment arm B - bevacizumab plus mFOLFOX6
干预措施: bevacizumab (Drug)
B
Treatment arm B - bevacizumab plus mFOLFOX6
干预措施: mFOLFOX6 (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: Baseline, at every 8-week intervals for 18 months then every 12 weeks thereafter until disease progression (up to Week 115)
Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from adverse event (AE) data (where the outcome was "Death").
次要结局
- Overall Survival (OS)(Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to Week 115))
- One Year Survival Probability(Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to 1 year))
- Two Year Survival Probability(Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to 2 years))
- Percentage of Participants With Objective Response (OR)(Baseline until disease progression or discontinuation of the study, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to Week 115)
- Duration of Response (DR)(Baseline until disease progression or discontinuation of the study, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to Week 115)
- Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score(Baseline [Day (D) 1 of Cycle (C) 1] then every 3 cycles thereafter and at the end of treatment (EOT) or withdrawal visit (up to Week 115))
- Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score(Baseline (D1 of C1) then every 3 cycles thereafter and at the EOT or withdrawal visit (up to 115 weeks))