Efficacy/Safety Study of Bevacizumab,Capecitabine,Oxaliplatin to Metastatic Colorectal Adenocarcinoma Elderly Patients. (BECOX)
A Non Randomized Phase II Trial to Assess Efficacy and Safety of Bevacizumab, Capecitabine and Oxaliplatin as First Line Treatment for Elderly Patients With Metastatic Colorectal Adenocarcinoma, Suitable for Polychemotherapy Treatment
研究概览
详细说明
The efficacy will be determined by objective response rate following RECIST criteria.
In several clinical trials with Bevacizumab, there has been demonstrated that elderly patients benefits as well as the younger of a combination therapy with chemotherapy plus Bevacizumab, but these results have come from subgroup analyses of trials not specifically design to test the effect of these combinations on the elderly. This clinical trial is specific only for elderly patients and we expect to confirm the benefits demonstrated in other clinical trials where the elderly patients were a number reduced.
This clinical trial includes 3 substudies:
- Assessment of tumor response of CRC liver metastases to treatment with Avastin in combination with Capecitabine and Oxaliplatin as first line treatment by dynamic ultrasound contrast.
Main objective: Assess the performance of dynamic contrast ultrasonography (CEUS, Contrast Enhanced UltraSound) with quantification of tumor perfusion in the evaluation of tumor response of liver metastases of colorectal carcinoma to treatment with Avastin in combination with Capecitabine and Oxaliplatin.
-Evaluation of the antiangiogenic activity of bevacizumab combined with oxaliplatin and capecitabine in first line treatment using MDCT perfusion studies in liver metastases of colorectal cancer in patients over 70 years.
Main objective:Determine whether the observed changes in perfusion CT studies performed at 2 weeks of starting treatment compared to baseline are significant predictors of free time to disease progression in patients in the trial and defined as the time since the start of treatment until objective progressive disease by RECIST criteria.
-Characterization of resistance to bevacizumab in colon cancer in elderly patients.
Main objective: To evaluate the involvement of serum markers and markers in the primary tumor in the resistance to bevacizumab.
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
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Barcelona、西班牙、08036
- Hospital Clinic I Provincial
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Burgos、西班牙、09005
- Hospital General Yague
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Lérida、西班牙、25198
- Hospital Arnau de Vilanova
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Madrid、西班牙、28046
- Hospital Universitario La Paz
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Madrid、西班牙、28223
- Hospital Quiron de Madrid
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Murcia、西班牙、30008
- Hospital Morales Meseguer
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Valencia、西班牙、46009
- Hospital La Fe de Valencia
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Valencia、西班牙、46014
- Hospital General de Valencia
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Valencia、西班牙、46017
- Hospital Doctor Peset
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Vigo、西班牙、36204
- Hospital Xeral Cies de Vigo
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Barcelona
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Hospitalet de Llobregat、Barcelona、西班牙、08906
- Hospital de L´Hospitalet
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Las Palmas
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Las Palmas de Gran Canaria、Las Palmas、西班牙、35010
- Hospital de Gran Canaria Doctor Negrín
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Madrid
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San Sebastián de los Reyes、Madrid、西班牙、28702
- Hospital Infanta Sofía
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Navarra
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Pamplona、Navarra、西班牙、31008
- Hospital de Navarra
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Valencia
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Játiva、Valencia、西班牙、46800
- Hospital Lluis Alcanyis
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Written informed consent.
- ECOG 0-1.
- Age ≥ 70 years.
- Histologically confirmed carcinoma of the colon and/or rectum.
- Metastatic disease non suitable for radical surgery.
- At least one measurable metastatic lesion (as per RECIST criteria). The index lesion must not be in a previously irradiated area.
- Non prior chemotherapy for metastatic disease. Adjuvant (or neo-adjuvant for rectal cancer patients) chemotherapy allowed if completed ≥ 12 months before inclusion.
- Life expectancy more than 3 months.
- Adequate renal function: creatinine ≤ 1.5 x UL and calculated creatinine clearance ≥ 30 mL/min.
- Adequate level function: AST and ALT ≤ 2.5 x UL (≤ 5 x UL if liver metastases), bilirubin ≤ 1.5 x UL.
- Adequate haematological function: Hb ≥ 9 gr/dl, neutrophils ≥ 1,5 x 109 /l and platelets ≥ 100000 x 109/l.
- Urine dipstick for proteinuria < 2+. If urine dipstick is ≥ 2+, 24 hour urine must demonstrate ≤ 1 g of protein in 24 hours.
- No clinical evidence or history of metastatic CNS disease.
- No prior Bevacizumab treatment.
Exclusion Criteria:
- Patients who previously received bevacizumab.
- Prior chemotherapeutic treatment for metastatic CRC.
- Prior treatment with monoclonal antibodies.
- Clinical evidence of brain metastases or history or evidence upon physical examination of CNS disease unless adequately treated.
- Past or current history (within the last 5 years prior to treatment start) of other malignancies except metastatic colorectal cancer (Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible).
- Clinically significant cardiovascular disease, for example CVA (≤ 6 months before treatment start), myocardial infarction (≤ 6 months before treatment start), unstable angina, NYHA ≥ grade 2, CHF, arrhythmia requiring medication, or uncontrolled hypertension.
- Intestinal occlusion/subocclusion.
- Chronic diarrhea.
- Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to entering this study.
- Known hypersensitivity to any of the study drugs.
- Current or recent (within 10 days of first dose of study treatment) daily use of aspirin (> 325 mg/day) or other NSAID.
- Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic (as opposed to prophylactic) purposes. Patients receiving (or considered candidate to receive) anticoagulants agents as prophylaxis of cardiovascular risk, should continue (or start) the appropriate treatment at study entry.
- History of venous thromboembolic or haemorrhagic events within 6 months prior to treatment.
- Patients with previous of arterial thromboembolic event.
- Evidence of bleeding diathesis or coagulopathy.
- Serious, non healing wound, ulcer, or bone fracture.
- Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to treatment, or anticipation of the need for major surgery during the course of the study.
- Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications.
- Patients of childbearing potential not willing to use effective means of contraception.
- Positive HIV serology.
- Known addiction to alcohol or other drugs.
- Patients included in other clinical trial
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：bevacizumab, capecitabine, oxaliplatin
6 cycles (3 weeks each one) of:
After the first 6 cycles of treatment, continuing only with bevacizumab and capecitabine |
6 cycles (3 weeks each one) of:
After the first 6 cycles of treatment, continuing only with bevacizumab and capecitabine
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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进展时间
大体时间：3年
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3年
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次要结果测量
结果测量 |
大体时间 |
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总生存期
大体时间：3年
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3年
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整体回复率
大体时间：3年
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3年
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Objective response rate following Response Evaluation Criteria In Solid Tumors (RECIST) criteria
大体时间：3 years
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3 years
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Number of treatment cycles administered
大体时间：3 years
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3 years
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Number of patients who have required dose reductions of either drug
大体时间：3 years
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3 years
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Safety of treatment according to the number of adverse events reported
大体时间：3 yeras
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3 yeras
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合作者和调查者
调查人员
- 学习椅：Jaime Feliu Batlle, MD、Grupo Español Multidisciplinario de Cáncer Digestivo
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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