A Phase 2 Multicenter Single Arm Clinical Trial of ABX-EGF Monotherapy in Subjects With Metastatic Colorectal Cancer Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 185
- 主要终点
- Number of Participants With Objective Tumor Response Through Week 16
研究概览
简要总结
The purpose of this study is to determine that panitumumab will have clinically meaningful anti-tumor activity in patients with metastatic colorectal cancer who have developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy.
详细描述
Panitumumab was administered once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons (eg, administrative decision). Participants then attended a safety follow-up visit 4 weeks from the last panitumumab infusion. Participants were subsequently contacted every 3 months from the last panitumumab infusion through month 24 to assess disease status and survival.
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
- •Pathologic diagnosis of colorectal adenocarcinoma (diagnostic tissue obtained by tissue biopsy)
- •Metastatic colorectal carcinoma
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- •Documented evidence of disease progression during, or following treatment, with fluoropyrimidine, irinotecan and oxaliplatin chemotherapy for metastatic colorectal cancer
- •Radiographic documentation of disease progression during or within 6 months following the most recent chemotherapy regimen is required
- •Bidimensionally measurable disease
- •Tumor expressing epidermal growth factor receptor (EGFr) by immunohistochemistry
- •At least 2 but no more than 3 prior chemotherapy regimens for metastatic colorectal cancer
- •Adequate hematologic, renal and hepatic function
排除标准
- •Symptomatic brain metastases requiring treatment
- •Patient with a history of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis
- •Use of systemic chemotherapy or radiotherapy within 30 days before enrollment
- •Prior epidermal growth factor receptor targeting agents
- •Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short (less than 1 week) serum half-life within 30 days before enrollment, or prior experimental or approved proteins with longer serum half-life (e.g., AvastinTM) within 6 weeks before enrollment
结局指标
主要结局
Number of Participants With Objective Tumor Response Through Week 16
时间窗: 16 weeks
Confirmed objective tumor response (complete or partial response) based on modified World Health Organization (WHO) criteria, through week 16. Tumor response was assessed by a central Independent Review Committee (IRC) and confirmation 4 weeks after initial assessment was required. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the sum of the product of the longest diameters (SPD) of index lesions taking as reference the Baseline SPD, and no new non-index lesions and no "unequivocal progression" of non-index lesions, or, the disappearance of all index lesions and persistence of one or more non-index lesions not qualifying for either CR or Progressive Disease.
Duration of Response
时间窗: Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.
The time from first objective response to first observed progression of disease or death if the death was due to disease progression (whichever comes first); participants who respond and have not progressed while on study or died for reasons other than disease progression while on study were censored at their last evaluable disease assessment date. Response (complete or partial response) was assessed per modified WHO criteria by the central IRC. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the sum of the product of the longest diameters (SPD) of index lesions taking as reference the Baseline SPD, and no new non-index lesions and no "unequivocal progression" of non-index lesions, or, the disappearance of all index lesions and persistence of one or more non-index lesions not qualifying for either CR or Progressive Disease.
次要结局
- Time to Response(Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.)
- Progression-free Survival Time(Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.)
- Time to Disease Progression(Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.)
- Number of Participants With Objective Tumor Response Throughout Study(Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.)
- Time to Treatment Failure(Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.)
- Duration of Stable Disease(Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.)
- Overall Survival(Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.)