NCT01202409已完成2 期
Phase II Study of Panitumumab in KRAS Wild-type Locally Advanced or Metastatic Adenocarcinoma of the Small Bowel or Ampulla of Vater
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Response Rate (RR)
研究概览
简要总结
The goal of this clinical research study is to learn if panitumumab can help to control advanced cancer of the small bowel or ampulla of Vater. The safety of this drug will also be studied.
详细描述
Panitumumab is designed to "turn off" a protein that is important in cell growth. This may stop the growth of cancer cells.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive the study drug during 14 day study "cycles."
On Day 1 of every cycle, you will receive panitumumab by vein over about 60-90 minutes.
Study Visits:
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
- •Patients must have histologically confirmed adenocarcinoma of the small bowel or ampulla of Vater that is either unresectable or metastatic.
- •Adequate tumor tissue available for KRAS mutational analysis or known KRAS wild-type status.
- •Prior progression on or intolerance to treatment with a fluoropyrimidine and oxaliplatin. Recurrence of disease within 6 months from the completion of adjuvant therapy with both a fluoropyrimidine and oxaliplatin is considered progression.
- •Patients must have measurable disease as per the revised Response Evaluation Criteria In Solid Tumors (RECIST) criteria (Version 1.1).
- •If radiation was previously received, the measurable disease must be outside the previous radiation field, unless this area has demonstrated evidence of radiographic growth.
- •A minimum of 2 weeks must have elapsed from completion of any prior chemotherapy or radiotherapy or surgery and the start date of study therapy.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 -
- •Adequate organ function including: a) Absolute neutrophil count (ANC) =/>1,000/ul; b) Platelets =/>75,000/ul; c) Total bilirubin =/< 1.5 x ULN; in patients with known Gilbert's syndrome direct bilirubin =/<1.5 x ULN will be used as organ function criteria, instead of total bilirubin; d) AST (SGOT)/ALT (SGPT) < 3 x ULN; e) Creatinine <2 x ULN.
- •Negative urine or serum pregnancy test in women with childbearing potential (defined as not post-menopausal for 12 months or no previous surgical sterilization), within one week prior to initiation of treatment.
- •The effects of panitumumab on the developing fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of study participation, and for six months following the completion of therapy. Should a woman become pregnant while participating in this study, she should inform her treating physician immediately.
- •Patients must sign an Informed Consent and Authorization indicating that they are aware of the investigational nature of this study and the known risks involved.
- •Magnesium level =/> lower limit of normal.
排除标准
- •Prior anti-epidermal growth factor receptor antibody therapy (eg. panitumumab or cetuximab) or prior small molecule anti-epidermal growth factor receptor therapy (eg. erlotinib) for adenocarcinoma of the small bowel or ampulla of Vater.
- •Patients may not be receiving any other investigational agents nor have received any investigational drug 30 days prior to enrollment.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit adherence with study requirements.
- •Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung.
- •Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with panitumumab, breast feeding must be discontinued.
- •Age <18 years. Because no dosing or adverse event data are currently available on the use of panitumumab in patients <18 years of age, children are excluded from this study.
研究组 & 干预措施
Panitumumab
Experimental
Starting Dose of Panitumumab: 9 mg/kg by vein over 60 minutes on day 1 of a 14 day cycle.
干预措施: Panitumumab (Drug)
结局指标
主要结局
Response Rate (RR)
时间窗: up to 100 weeks
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
次要结局
- Overall Progression-free Survival (PFS) for CAPOX and Panitumumab(7.6 months)
研究者
研究点 (1)
Loading locations...
相似试验
终止
1 期
Trial of Panitumumab Cisplatin, Fluourouracil and Docetaxel in Locally Advanced or Metastatic Gastric CancerGastric CancerNCT01716546Hellenic Oncology Research Group51
已完成
2 期
Safety and Efficacy Study of Panitumumab+Irinotecan in Patients Wild-Type (WT) KRAS Metastatic Colorectal Cancer Refractory to Irinotecan Based Chemotherapy (SPECTRA)Metastatic Colorectal CancerNCT00958386Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)61
撤回
2 期
Study of Panitumumab in the Treatment of Carcinoid SyndromeCarcinoid SyndromeNCT01172717Boston Medical Center
已完成
2 期
Evaluating Panitumumab (ABX-EGF) Monotherapy in Patients With Metastatic Colorectal Cancer Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin ChemotherapyMetastatic CancerColorectal CancerNCT00083616Amgen185
已完成
2 期
Panitumumab (ABX-EGF) Monotherapy in Patients With Metastatic Colorectal CancerMetastasesColorectal CancerNCT00089635Amgen203