EUCTR2012-005422-30-DE进行中（未招募）1 期
Randomized Phase II study for evaluation of efficacy and safety of maintenance treatment with 5-FU/FA plus panitumumab vs. 5-FU/FA alone after prior induction treatment with mFOLFOX6 plus panitumumab and re-induction with mFOLFOX6 plus panitumumab in case of progression for first-line treatment of patients with metastatic colorectal cancer
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
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
- •- Signed written informed consent
- •- Male or female >/= 18 years
- •- Histologically proven metastatic colorectal cancer
- •- Molecular testing showing KRAS wild type in colorectal carcinoma cells
- •- Life expectancy > 12 weeks
- •- At least one measurable lesion according to RECIST 1.1
- •- Adequate bone marrow, liver, kidney, organ and metabolic function
- •- ECOG perfomance status 0-1
- •- Woman of child-bearing potential must have a negative pregnancy test
- •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 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 400
排除标准
- •- Previous treatment for colorectal cancer in the metastatic setting with the exception that patients with urgent need of immediate treatment (high tumor load, symptoms) may have received one cycle of any FOLFOX regimen (no capecitabine!) in case of yet unconfirmed RAS status
- •- Previous EGFR-targeting therapy
- •-Complete or partial DPD-deficiency. DPD deficiency can be evaluated by measuring the uracil plasmalevel or by genotyping of the DPD-coding gene (DPYD).
- •- < 6 months after end of adjuvant therapy (previous
- •chemoradiation for rectal cancer is accepted for inclusion into
- •the trial and does not account as adjuvant therapy)
- •- Known brain metastases unless adequately treated (surgery or radiotherapy) with no evidence of progression and neurologically stable off anticonvulsants and steroids
- •- Chronic inflammatory bowel disease
- •- Peripheral polyneuropathy >/= NCI-CTC V 4.03 grade 2
- •- Other previous malignancies with the exception of a history of previous curatively treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix or other curatively treated malignat disease without recurrance after at least 5 years of follow-up
- •- Significant disease that, in the investigator´s opinion, would exclude the patient from the study
- •- History of cardiac deseases, defined as:
- •° Congestive heart failure > New York Aheart Assiciation (NYHA) class 2
- •° Active coronary artery disease (myocardial infarction more than 6 months prior to start of study treatment is allowed)
- •° Cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted)
- •° Uncontrolled hypertension (defined as blood preasure >/= 160 mmHg systolic and/or >/= 90 mmHg diastolic on medication)
- •- Patients with interstitial lung disease, e. g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
- •- Known HIV, hepatitis B or C infection
- •- Known hypertensitivity reaction to any of the study components
- •- Radiotherapy, major surgery or any investigational drug 21 days before registration
- •- Pregnancy or lactation or planning to be pregnant during treatment and within 6 months after the end of treatment
- •- Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for at least an additional 6 months after the end of treatment
- •- Known alcohol or drug abuse
- •- Any condition that is unstable or could jeopardize the safety of the patient and his compliance in the study
研究者
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