A Phase 2 Clinical Trial of Panitumumab in Combination With Irinotecan Chemotherapy as 2nd-line Therapy in Subjects With Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- objective response rate
研究概览
简要总结
The purpose of this study is to assess the objective response rate (ORR) when panitumumab is administered in combination with irinotecan as 2nd-line therapy in subjects with previously treated metastatic colorectal cancer (mCRC).
详细描述
Aside from limited cases of resectable metastatic disease, mCRC cannot be cured with the currently available chemotherapy regimens, and there is a continued need to improve the current treatment.
Panitumumab has demonstrated objective tumour response, increase in progression free survival and has an acceptable safety profile in clinical studies in patients with metastatic colorectal cancer when used as a monotherapy or in combination with irinotecan (Meropol et al, 2003; Berlin et al, 2004; Hecht et al, 2004; Malik et al, 2005).
The addition of panitumumab to chemotherapy is expected to enhance the treatment effect of chemotherapy.
This is a Phase II, single-arm, multi-centre study. Eligible subjects will be enrolled and treated with second-line combination therapy consisting of panitumumab and irinotecan.
Prior to study entry and in order to confirm eligibility, the investigator or designee will review existing radiological images in addition to any other relevant clinical documents (reports, notes, etc.) to ensure the subject has failed or relapsed while on or after one prior chemotherapy regimen.
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
- •Man or woman > 18 years of age
- •Competent to comprehend, sign, and date an IEC-approved informed consent form
- •Histologically or cytologically-confirmed metastatic adenocarcinoma of the colon or rectum.
- •Radiographically documented disease progression per modified RECIST criteria either while receiving or ≤ 6 months after the last dose of prior first-line chemotherapy for mCRC
- •At least 1 uni-dimensionally measurable lesion of at least 20 mm per modified RECIST criteria.
- •If subject has prior history of cancer other than colorectal carcinoma, basal cell carcinoma, or cervical carcinoma in situ, then subject must not have had treatment or active disease within 5 years.
- •Prior radiotherapy is acceptable.
- •One and only one prior chemotherapy regimen for mCRC consisting of first-line fluoropyrimidine-based chemotherapy.
- •ECOG performance status of 0, 1 or 2
- •Life expectancy ≥ 3 months
- •Hematologic function:ANC > 1.5 x 109/L, Platelet count > 100 x 109/L, Hemoglobin > 10 g/dL
- •Renal function: Creatinine < 1.5 mg/dL
- •Hepatic function: AST and ALT < 3 x ULN (if liver metastases < 5 x ULN)
- •Bilirubin < 2 x ULN
排除标准
- •No more than one prior chemotherapy regimen for mCRC consisting of first-line fluoropyrimidine-based chemotherapy. (Prior adjuvant fluoropyrimidine-based chemotherapy is allowed)
- •Prior systemic therapy for the treatment of metastatic colorectal carcinoma with the exception of adjuvant fluoropyrimidine-based chemotherapy given at least 6 months prior to enrolment.
- •Systemic chemotherapy, hormonal therapy, immunotherapy or experimental or approved proteins/antibodies (eg, bevacizumab) ≤ 30 days before inclusion
- •Unresolved toxicities from prior systemic therapy that, in the opinion of the investigator, does not qualify the patient for inclusion
- •Central nervous system/brain metastases
- •Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment or a history of ventricular arrhythmia
- •Prior anti-EGFr antibody therapy (eg, cetuximab) or treatment small molecule EGFr tyrosine kinase inhibitors (eg, erlotinib)
- •History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest CT scan
- •Treatment for systemic infection within 14 days before initiating study treatment
- •Radiotherapy ≤ 14 days prior to inclusion. Patients must have recovered from all radiotherapy-related toxicities
- •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
- •History of any medical condition that may increase the risks associated with study participation or may interfere with the interpretation of the study results
- •Known positive test for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection
- •subject allergic to the ingredients of the study medication or to Staphylococcus protein A
- •Any co-morbid disease that would increase risk of toxicity
- •Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures
- •Any investigational agent within 30 days before enrolment
- •Must not have had a major surgical procedure within 28 days of randomization
- •Subject who is pregnant or breast feeding
- •Woman or man of childbearing potential not consenting to use adequate contraceptive precautions i.e. double barrier contraceptive methods
- •Subject unwilling or unable to comply with study requirements
研究组 & 干预措施
1
干预措施: Panitumumab and CPT-11 (Drug)
结局指标
主要结局
objective response rate
时间窗: 2007-2010
次要结局
- disease control rate, duration of response, time to response, progression-free survival, time to progression,time to treatment failure,duration of stable disease(2007-2010)
- adverse events(2007-2010)