NCT01345526已完成2 期
A Double Blind Placebo Controlled Randomized Phase II Study Evaluating the Efficacy and Safety of the Prophylactic Use of Doxycycline +/- Vitamin K Cream in First Line mCRC Patients Treated With Erbitux and FOLFIRI.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 4
- 主要终点
- Occurrence of acne-like skin rash grade ≥ 2 (according to the CTCAE) version 4.02) during the 8 weeks of skin treatment.
研究概览
简要总结
The aim of this Phase 2, two-arm, randomized, double blind placebo controlled study is to evaluate the efficacy of combination therapy of doxycycline and Vitamin K1 compared to doxycycline plus placebo for the prevention of acne-like skin rash in mCRC patients receiving first line cetuximab treatment.
详细描述
The aim of this Phase 2, two-arm, randomized, double blind placebo controlled study is to evaluate the efficacy of combination therapy of doxycycline and Vitamin K1 compared to doxycycline plus placebo for the prevention of acne-like skin rash in mCRC patients receiving first line cetuximab treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomized Phase II Trial assessing the prevention of acne like Skin rash
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
- •Written informed consent must be given
- •Patient ≥ 18 years
- •Histologically proven and measurable metastatic adenocarcinoma of the colon or rectum (according to modified RECIST criteria v.1.1)
- •Patients eligible for Erbitux and FOLFIRI treatment K-Ras wild type tumour
- •Metastatic disease
- •Life expectancy of at least 12 weeks
- •WHO performance status of 0 or 1
- •Effective contraception for both male and female patients if the risk of conception exists
- •Adequate organ function
- •Adequate bone marrow, hepatic and renal function (Hemoglobin > 10.0 g/dL, platelet count > 100 x 109/L, absolute neutrophil count > 1.5 x 109/L; ALAT, ASAT < 2.5 x ULN (upper limit of normal range) or < 5x ULN in case of liver metastasis; Alkaline phosphatase < 2.5 x ULN; Total bilirubin < 1.5 x ULN; Creatinine clearance > 50 mL/min (calculated according to Cockcroft and Gault formula)).
排除标准
- •Prior treatment for metastatic disease (adjuvant therapy with 5-FU/oxaliplatin based regimens) allowed if stopped 6 months prior to registration on study
- •Prior treatment with EGFR inhibitor
- •Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to study entry
- •Administration of any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drugs
- •Concurrent chronic systemic immune therapy, chemotherapy, radiation therapy or hormone therapy not indicated in the study protocol
- •Any active dermatological condition > grade 1 at baseline possibly interfering with or influencing the results or conduct of the present study
- •Brain metastasis (known or suspected)
- •Significant impairment of intestinal resorption (e.g. chronic diarrhea, inflammatory bowel disease)
- •Any other uncontrolled concomitant illness, including serious uncontrolled intercurrent infection
- •Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction within the last twelve months, significant arrhythmias)
- •Known allergy or any other adverse reaction to any of the study drugs or to any related compound.
- •Any organ allograft requiring immunosuppressive therapy.
- •Pregnancy (absence to be confirmed by serum/urine beta human chorion gonadotrophin (HCG)) or breast-feeding.
- •Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix surgically cured or adequately treated.
- •Known drug abuse / alcohol abuse
- •Legal incapacity or limited legal capacity
- •Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and followup schedule; those conditions should be discussed with the patient before registration in the trial.
- •Medical or psychological condition which, in the opinion of the investigator, would not permit the patient to complete the study or meaningfully sign informed consent.
- •Known M. Meulengracht (Gilbert´s disease) or DPD-insufficiency
- •Known coagulation disorders
- •Ongoing or planned treatment with coumarin derivates
结局指标
主要结局
Occurrence of acne-like skin rash grade ≥ 2 (according to the CTCAE) version 4.02) during the 8 weeks of skin treatment.
时间窗: Week 8
PFS rate, toxicity, compliance
时间窗: Week 8
次要结局
未报告次要终点
研究者
Ralf Hofheinz
Head TTZ University Hospital Mannheim
Universitätsmedizin Mannheim
研究点 (4)
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