A Randomized, Multicenter Phase 3 Study to Compare the Efficacy of Panitumumab in Combination With Chemotherapy to the Efficacy of Chemotherapy Alone in Patients With Previously Treated Metastatic Colorectal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 1,186
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
The purpose of this study is to evaluate the treatment effect of panitumumab plus FOLFIRI compared to FOLFIRI alone as second 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 (mCRC)
- •One and only one chemotherapy regimen for mCRC consisting of first-line 5-FU -based chemotherapy
- •Radiologically documented disease progression per modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria during treatment or within 6 months of last dose of first-line chemotherapy
- •At least 1 uni-dimensionally measurable lesion of at least 20 mm per modified RECIST
- •Eastern Cooperative Oncology Group (ECOG) status of 0, 1, or 2
- •Paraffin-embedded tumor tissue from the primary tumor or metastasis available for central analyses
- •Adequate hematologic, renal, and hepatic functions
- •Negative pregnancy test within 72 hours of enrollment
- •Other protocol-specified criteria may apply
排除标准
- •History of or known presence of central nervous system (CNS) metastases
- •History of another primary cancer within 5 years of randomization
- •Prior irinotecan therapy
- •Prior anti-epidermal growth factor receptor (EGFr) antibody therapy or treatment with small molecule EGFr inhibitors
- •Any investigational agent or therapy within 30 days before randomization
- •Known allergy or hypersensitivity to irinotecan, 5-FU or leucovorin
- •History of interstitial lung disease or evidence of interstitial lung disease on baseline chest computed tomography (CT) scan
- •Active inflammatory bowel disease or other bowel disease causing chronic diarrhea
- •Known positive tests for human immunodefiency virus (HIV), hepatitis C viris (HCV), acute or chronic active hepatitis B virus (HBV)
- •Major surgery within 28 days of randomization or minor surgical procedure within 14 days of randomization
- •Pregnant or breast-feeding
- •Man or woman of child-bearing potential not consenting to use adequate contraceptive methods or abstinence during the course of the study and for 6 months after last study drug administration (women) or 1 month after last study drug administration (men)
- •Other protocol-specified criteria may apply
研究组 & 干预措施
Panitumumab Plus FOLFIRI
Participants received panitumumab as an intravenous (IV) infusion at a dose of 6 mg/kg plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-fluorouracil (5-FU), leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
干预措施: Panitumumab (Drug)
Panitumumab Plus FOLFIRI
Participants received panitumumab as an intravenous (IV) infusion at a dose of 6 mg/kg plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-fluorouracil (5-FU), leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
干预措施: FOLFIRI (Drug)
FOLFIRI Alone
Participants received standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment is administered in cycles every two weeks.
干预措施: FOLFIRI (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: From randomization until the data cut-off date of 8 April 2008. Maximum follow-up time was 17 months.
Progression-free survival was defined as the time from randomization to first disease progression per modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria or death, based on independent central radiological assessment. 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.
Overall Survival
时间窗: From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months
Overall survival was defined as the time from randomization to the date of death. Participants who had not died by the analysis data cutoff date had their time of death censored at their last contact date.
次要结局
- Percentage of Participants With an Objective Response(Every 8 weeks until disease progression up to the data cut-off date of 30 April 2009. Maximum time on follow-up was 33 months.)
- Time to Disease Progression(From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months)
- Duration of Response(From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months)
- Number of Participants With Adverse Events (AEs)(From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months.)