EUCTR2010-023671-26-DE进行中（未招募）1 期
Panitumumab after Resection of Liver Metastases from Colorectal Cancer in RAS Wild-type Patients-PARLIM- - PARLIM
Klinikum der Universität München-Großhadern0 个研究点目标入组 111 人开始时间: 2011年5月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 111
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patient has provided written informed consent.
- •2. R0/1-resection of liver metastasis, at least four weeks but not longer than 8 weeks ago (submission of the pathologist´s report to exclude R2 resection status is mandatory for randomisation)
- •3. Histologically confirmed diagnosis of metastatic colorectal cancer confined to the liver
- •4. RAS wild-type of the tumor, tested in:
- •KRAS exon 2 (codons 12/13)
- •KRAS exon 3 (codons 59/61)
- •KRAS exon 4 (codons 117/146)
- •NRAS exon 2 (codons 12/13)
- •NRAS exon 3 (codons 59/61)
- •NRAS exon 4 (codons 117/146)
- •5. Age 18 years or older
- •6. ECOG performance status 0-1
- •7. Females with child-bearing potential must use adequate contraceptive measures
- •8. Exclusion of pregnancy
- •9. Relevant toxicities of previous treatments must have subsided
- •10. Magnesium = lower limit of normal; Calcium = lower limit of normal
- •11. Normal cardiac function demonstrated by ECG and echocardiogram (LVEF = 55%)
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •12. Adequate organ function as defined by Table 1:
- •Table 1: Adequate Hepatic and Renal Function Values
- •SYSTEM LABORATORY VALUES
- •Hematologic
- •ANC (absolute neutrophil count) = 1.5 G/L
- •Leucocytes > 3.0 G/L
- •Hemoglobin = 9 g/dL
- •Platelets = 100 G/L
- •Albumin = 2.5 g/dL
- •Serum bilirubin <=2 mg/dL
- •AST and ALT <= 3 x ULN
- •Serum Creatinine <= 1.5 mg/dL
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Known manifestations of metastatic disease
- •2. Progression during preoperative treatment
- •3. RAS mutation of the tumor
- •4. Contraindication against therapy with 5-Fluorouracil/ folinic acid or oxaliplatin
- •5. Known intolerability of panitumumab
- •6. Known DPD deficiency
- •7. Polyneuropathy > grade 1 (NCI-CTCv4) which precludes the use of oxaliplatin
- •8. Evidence of ascites or cirrhosis
- •9. Patient is pregnant or lactating or planning to become pregnant within 6 months after end of treatment
- •10. Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment
- •11. Has had a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrolment, or there is an anticipated need for major surgical procedure during the course of the study. This excludes minor surgical procedures like implantation of intravenous portsystems (7 days prior enrolment) or central venous catheters (2 days prior enrolment).
- •12. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) <=1 year before enrolment/randomisation
- •13. History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
- •14. Has a concurrent disease or condition that would make the subject inappropriate for study participation or would interfere with the subject’s safety.
- •15. Has any psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
- •16. Requires concurrent cancer therapy (chemotherapy, radiation therapy, biologic therapy, immunotherapy, or hormonal therapy) while on study.
- •17. Requires concurrent treatment with an investigational agent, participation in another clinical trial, or any specifically prohibited medication while on study.
- •18. Has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to 5-Fluorouracil, folinic acid, oxaliplatin, or panitumumab.
- •19. Other active malignancy
- •20. Known alcohol abuse or drug addiction
- •21. Incapability to give informed consent
研究者
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