A Phase 2 Multicenter Single Arm Clinical Trial of ABX-EGF Monotherapy in Subjects With Metastatic Colorectal Cancer Whose Tumors Express Low or Negative EGFr Levels of Immunohistochemistry 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
- 203
- 主要终点
- Duration of Response
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.
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 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 low to negative levels of 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 anti-EGFr antibody therapy with the exception of the small molecule EGFr tyrosine kinase inhibitors, which are permitted
- •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 within 6 weeks before enrollment
研究组 & 干预措施
Panitumumab
Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
干预措施: Panitumumab (Drug)
结局指标
主要结局
Duration of Response
时间窗: From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.
Kaplan-Meier estimate of time time from first objective response to first observed progression of disease or death if the death was due to disease progression (whichever comes first) among participants who had a response at any time on study. Participants who responded and did not progress while on study or who died for reasons other than disease progression while on study were censored at their last evaluable assessment date.
Objective Tumor Response Through Week 16
时间窗: From enrollment through Week 16
Confirmed objective tumor response was defined as a complete response or partial response from enrollment through Week 16. Tumor response was monitored, beginning at Week 8, per a modified version of the World Health Organization (WHO) criteria for tumor response and progression by an independent review committee central assessment. Complete response was defined per modified WHO criteria as disappearance of all lesions (index and non-index). Partial response was defined as ≥ 50% decrease from Baseline in the sum of the products of the longest diameters (SPD) of index lesions. Scans were required to confirm a complete or partial response no earlier than 4 weeks from the time a response of complete or partial response was first documented.
次要结局
- Time to Initial Objective Response(From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.)
- Objective Tumor Response Throughout the Study(From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.)
- Progression-free Survival Time(From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.)
- Overall Survival(From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.)
- Time to Treatment Failure(From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.)
- Time to Disease Progression(From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.)
- Duration of Stable Disease(From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.)