A Randomized, Multicenter, Phase 3 Study to Compare the Efficacy of Panitumumab in Combination With Oxaliplatin/ 5-fluorouracil/ Leucovorin to the Efficacy of Oxaliplatin/ 5-fluorouracil/ Leucovorin Alone in Patients With Previously Untreated Metastatic Colorectal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 1,183
- 主要终点
- Progression-free Survival
研究概览
简要总结
The purpose of this study is to determine the treatment effect of panitumumab in combination with FOLFOX compared to FOLFOX alone as first line therapy for metastatic colorectal cancer
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
- •Man or woman at least 18 years old
- •Diagnosis of metastatic colorectal cancer
- •At least 1 uni-dimensionally measurable lesion of at least 20 mm per modified RECIST
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •Paraffin-embedded tumor tissue from the primary tumor or metastasis available for central analyse
排除标准
- •History or known presence of central nervous system (CNS) metastases
- •History of another primary cancer, except: Curatively treated in situ cervical cancer, or Curatively resected non-melanoma skin cancer, or Other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 5 years before randomization
- •Prior chemotherapy or systemic therapy for the treatment of metastatic colorectal carcinoma except: adjuvant fluoropyrimidine-based chemotherapy or prior fluoropyrimidine therapy administered solely for the purpose of radiosensitization
- •Prior oxaliplatin therapy
- •Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (eg, cetuximab) or treatment with small molecule EGFr inhibitors (eg, erlotinib)
- •Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 1 year prior to randomization History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computed tomography (CT) scan
- •Active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as > Common terminology criteria (CTC) grade 2 [CTCAE version 3.0])
- •Peripheral sensory neuropathy with functional impairment
研究组 & 干预措施
FOLFOX + Panitumumab
Participants received panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
干预措施: Panitumumab (Drug)
FOLFOX + Panitumumab
Participants received panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
干预措施: FOLFOX regimen (Drug)
FOLFOX
Participants received FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
干预措施: FOLFOX regimen (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: From randomization until the data cutoff date of 30 September 2008. Maximum follow-up time was 109 weeks.
Progression-free survival (PFS), assessed by central radiological assessment, was defined as the time from randomization to disease progression per modified response evaluation criteria in solid tumors (RECIST) criteria or death. Participants who were alive but did not meet criteria for progression by the data cutoff date were censored at their last evaluable disease assessment date. Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions.
次要结局
- Overall Survival(From randomization until the data cutoff date of 28 August 2009. Maximum time on follow-up was 153 weeks.)
- Percentage of Participants With an Objective Response(Every 8 weeks until disease progression up to the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks.)
- Number of Participants With Adverse Events (AEs)(From randomization until the data cut-off date of 28 August 2009; Maximum time on follow-up was 153 weeks.)
- Duration of Response(Every 8 weeks until disease progression up to the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks.)
- Time to Progression(From randomization until the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks.)