A Single Arm Multicentre Phase II Study of Panitumumab in Combination With Irinotecan/5-fluorouracil/Leucovorin in Patients With Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 154
- 主要终点
- Objective Response Rate
研究概览
简要总结
To estimate the effect of KRAS mutation status (Wild-type versus Mutant) on objective response rate and other measures of efficacy for patients treated with panitumumab in combination with a chemotherapy regimen of irinotecan, 5-fluorouracil, and leucovorin (FOLFIRI) as first-line therapy for metastatic colorectal cancer (mCRC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Diagnosed with histologically- or cytologically-confirmed metastatic adenocarcinoma of the colon and/or rectum.
- •Measurable disease according to modified RECIST guidelines.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or
- •Paraffin-embedded tissue or unstained tumour slides from primary or metastatic tumour available for central lab analysis.
- •Adequate haematologic, renal, hepatic and metabolic function.
排除标准
- •Central nervous system metastases.
- •Prior systemic therapy for the treatment of metastatic colorectal carcinoma with the exception of adjuvant fluoropyrimidine-based chemotherapy given at least six months prior to initiating study treatment.
- •Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (e.g. cetuximab) or treatment with small molecule EGFr tyrosine kinase inhibitors (e.g. erlotinib).
- •Prior radiotherapy within 14 days prior to screening, and for which all signs of early radiological toxicity have not abated.
- •Significant cardiovascular disease including unstable angina or myocardial infarction within six months before initiating study treatment or a history of ventricular arrhythmia.
- •History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest computed tomography (CT scan.
- •Active inflammatory bowel disease or other bowel disease causing chronic diarrhoea (defined as > 4 loose stools per day).
- •History of Gilbert's syndrome or dihydropyrimidine deficiency.
- •Known positive test for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection.
- •Any investigational agent within 30 days before initiation of study treatment.
- •Must not have had a major surgical procedure within 28 days prior to initiation of study treatment.
- •Subject who is pregnant or breast-feeding.
- •Woman or man of childbearing potential not consenting to use adequate contraceptive precautions during the course of the study and for six months after the last study drug administration for women, and one month for men.
- •Other protocol specified criteria and specific details may apply.
研究组 & 干预措施
Panitumumab plus FOLFIRI
Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
干预措施: Panitumumab (Drug)
Panitumumab plus FOLFIRI
Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
干预措施: FOLFIRI (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks
Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments are based on investigator review of scans using modified Response Evaluation Criteria in Solid Tumors (RECIST) V1.0 criteria. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Participants with no post-baseline assessment were considered non-responders. Complete Response (CR): disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions but persistence of 1 or more non-target lesions not qualifying for either CR or progressive disease (PD) and no new lesions.
次要结局
- Objective Response by 17 Weeks(Up to Week 17)
- Disease Control Rate(Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks)
- Duration of Response(Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks.)
- Time to Disease Progression(From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.)
- Duration of Stable Disease(Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks.)
- Time to Treatment Failure(From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.)
- Time to Disease Relapse Following Surgical Intervention(From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.)
- Time to Initial Objective Response(Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks.)
- Progression-free Survival(From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.)
- Resection Rate(From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.)